医疗器械注册管理办法中英文翻译
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
Article 4 The state shall classify medical devices and administer them based on this classification.境内第一类医疗器械由设区的市级（食品）药品监督管理机构审查，批准后发给医疗器械注册证书。
Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts.境内第二类医疗器械由省、自治区、直辖市（食品）药品监督管理部门审查，批准后发给医疗器械注册证书。
Domestic Class II medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.境内第三类医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。
Domestic Class III medical device shall be inspected, approved and granted with registration certificate by State Food Drug Administration.境外医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。
Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration.台湾、香港、澳门地区医疗器械的注册，除本办法另有规定外，参照境外医疗器械办理。
Taiwan, Hongkong and Macao’s medical device registration shall refer to the regulation of imported medical device.医疗器械注册证书有效期4年。
Medical devices certificate is valid for 4 years.第五条医疗器械注册证书由国家食品药品监督管理局统一印制，相应内容由审批注册的（食品）药品监督管理部门填写。
Article 5 Medical devices registration certificate shall be pressed by State Food Drug Administration and the content shall be filled in by inspection department of food drug administration.注册号的编排方式为：Registration is arranged as the following:×（×）1(食)药监械（×2）字××××3第×4××5××××6号。
其中：X (X) 1 SFDA (X2) 字××××3第×4××5××××6号×1 为注册审批部门所在地的简称：X 1 : Shortened form of registration inspection department ‘s locus境内第三类医疗器械、境外医疗器械以及台湾、香港、澳门地区的医疗器械为“国”字；“国” is for domestic Class III medical devices, imported medical devices and medical devices of Taiwan, Hongkong and Macao.境内第二类医疗器械为注册审批部门所在的省、自治区、直辖市简称；境内第一类医疗器械为注册审批部门所在的省、自治区、直辖市简称加所在设区的市级行政区域的简称，为××1（无相应设区的市级行政区域时，仅为省、自治区、直辖市的简称）；×2为注册形式（准、进、许）：“准”字适用于境内医疗器械；“进”字适用于境外医疗器械；“许”字适用于台湾、香港、澳门地区的医疗器械；××××3为批准注册年份；×4为产品管理类别；××5为产品品种编码；××××6为注册流水号。
医疗器械注册证书附有《医疗器械注册登记表》（见本办法附件1），与医疗器械注册证书同时使用。
Medical device registration certificate is attached with medical device registration record, and shall be used along with medical device registration certificate.第六条生产企业提出医疗器械注册申请，承担相应的法律义务，并在该申请获得批准后持有医疗器械注册证书。
Manufacturers put forward medical device registration application, take relevant regal responsibility and keep medical device registration certificate after getting application approval.办理医疗器械注册申请事务的人员应当受生产企业委托，并具有相应的专业知识，熟悉医疗器械注册管理的法律、法规、规章和技术要求。
Individuals who do medical device registration application should be authorized by manufacturer, possess professional knowledge, are familiar with medical device registration administration law, regulation, rules and technical requirement.申请境外医疗器械注册的，境外生产企业应当在中国境内指定机构作为其代理人，代理人应当承担相应的法律责任；并且，境外生产企业应当委托中国境内具有相应资格的法人机构或者委托其在华机构承担医疗器械售后服务。
When doing imported medical devices registration, the overseas manufactures shall authorize an unit to be their agent in Chinese territory and the agent should take relevant legal responsibilities.Meanwhile overseas manufactures shall authorize qualified body corporate or theirs own organ located in China to do after sales service.第七条申请注册的医疗器械，应当有适用的产品标准，可以采用国家标准、行业标准或者制定注册产品标准，但是注册产品标准不得低于国家标准或者行业标准。
医疗器械监督管理条例英文版
Regulations for the Supervision and Administration of Medical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the People's Republic of China shall comply with the Regulation.Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide. The drug administration of the local government at county level and above is responsible for supervision and administration of medical devices in each administrative region. The drug regulatory authority under the State Council shall coordinate with other departments under the State Council, responsible for comprehensive economic administration, in the implementation of policies for the medical device industry.Article 5 The State shall classify medical devices and administer them based on this classificationClass I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.Article 6 Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority.Chapter II The Administration of Medical DevicesArticle 7 The State encourages the research and development of new medical devices. "New medical devices" refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council.New medical devices that have completed clinical trials and passed experts' evaluation and review organized by the drug regulatory authority under State Council, shall receive a new product certificate after being approved by the same organization.Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production.Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions. The drug regulatory authority under the State Council is responsible for the inspection and approval of clinical trial or verification of class III medical devices.Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial or verification, in accordance with the related provisions of the drug regulatory authority under the StateCouncil.The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the State Council.Article 10 Medical institutions may develop medical devices to serve their own clinical needs, and use them within their own institution under the guidance of licensed medical practitioners.Class II medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority of the government at provincial level and above. Class III medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority under the State Council.Article 11 When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issued by the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.Article 12 When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions of the drug regulatory authority under the State Council.The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.Article 13 In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change.Article 14 The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires.When the manufacturing of a medical device is stopped continuously for more than 2 years, its registrationcertificate is automatically invalidated.Article 15 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.National standards of medical devices shall be formulated jointly by the standardization authority and the drug regulatory authority under the State Council. Professional standards of medical devices shall be formulated by the drug regulatory authority under the State Council.Article 16 The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.Article 17 The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.Article 18 The State implements a system of re-evaluation and obsolescence for medical devices, the details of which shall be formulated by drug regulatory authority under the State Council after consulting with other related authorities under the State Council.Chapter III Administration of Production, Distribution and Useof Medical DevicesArticle 19 Enterprises manufacturing medical devices shall meet the following conditions:1. Possess professional technical personnel required for the manufacture of its medical devices;2. Possess facility and environment required for the manufacture of its medical devices;3. Possess equipment required for the manufacture of its medical devices;4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.Article 20 Establishment of manufacturing of class I medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing manufacturing of class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License.The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtainingthe manufacturing enterprise license.Article 22 The State implements a mandatory safety certification system for certain class III medical devices.A specific product list shall be established by the drug regulatory authority under the State Council, jointly with the quality and technology supervision authority.Article 23 Enterprises distributing medical devices shall meet the following conditions:1. Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;2. Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;3. Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;Article 24 Establishing of distribution of class II and/or class III medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing an enterprise distributing class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 25 The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 30 working days whether the licenses for manufacturing or distributing enterprises of medical devices can be issued, counting from the date of acceptance of the application. When a license is not issued, a written explanation shall be given to the applicant.Article 26 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License, and shall verify the certificates of qualified products.Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Medical institutions shall not use medical devices without registration, or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Article 27 Medical institutions shall not re-use medical devices labeled for single use, shall destroy them after use and establish a record, according to relevant provisions of the country.Article 28 The State shall establish a quality incident reporting system and a warning system of medical devices. Implementation details shall be stipulated by the drug regulatory authority under the State Council, in conjunction with the health authority and family planning authority under the State Council.Chapter IV Supervision of Medical DevicesArticle 29 The drug regulatory authorities of governments at county level and above shall appoint medical device monitors within their organization, who are responsible for the supervision and inspection of medical device manufacturing enterprises, distribution enterprises and medical institutions within their own administrative regions. When necessary, monitors may take product samples and ask for relevant materials according to the provisions promulgated by the drug regulatory authority under the State Council. Institutions and individuals concerned shall not decline cooperation or be deceitful in the monitoring process. The monitors shall be responsible to keep collected samples and materials confidential.Article 30 The State implements an accreditation system for the qualification of the testing institutions of medical devices. Only testing institutions accredited by the drug regulatory authority in conjunction with the quality and technical supervision authority under the State Council may conduct medical device test.Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacture, distribution and technical consultation related to the devices tested.Article 31 For products having caused or which may potentially cause quality incidents, the drug regulatory authority of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.Article 32 The drug regulatory authority of the governments at provincial level and above shall revoke the registration certificates of medical devices of which safety and effectiveness can not be ensured. Medical devices whose registration certificates have been revoked shall not be manufactured, distributed and used. Those already produced or imported shall be dealt with by the drug regulatory authority of government at county level and above.Article 33 The drug regulatory authorities of the government of the municipality consisting of districts and above, which perform product registrations in violation of these regulations, shall be ordered by the drug regulatory authority under the state council to correct the violations within a defined period. For those not corrected within the period, the product registration certificates may be revoked and the events may be made public.Article 34 Advertisements of medical devices shall be reviewed and approved by the drug regulatory authority of governments at provincial level and above, and shall not be published, broadcasted, circulated or posted before the approval.The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory authority under the State Council or the drug regulatory authority of the governments of provinces, autonomous regions and municipalities directly under the Central Government.Chapter V PenaltiesArticle 35 In cases of manufacturing medical devices without product registration certificates, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and related illegal income. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times the total sum of the illegal income shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in serious cases, the drug regulatory authorities of the governments at the provinces, autonomous regions and municipalities directly under the Central Government shall revoke the Medical Device Manufacturing Enterprise License; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 36 In cases of manufacturing class II and class III medical devices without a Medical Device Manufacturing Enterprise License, in violation of these regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 37 In cases of manufacturing medical devices not in conformity with national standards or professional standards for medical devices, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an warning, followed with an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the product registration certificates shall be revoked by the authorities originally issued the certificates; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 38 In cases of Distribution of class II and class III medical devices without a Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 39 In cases of distributing medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drugregulatory authority of governments at county level and above shall issue an order to stop the distribution, confiscate all of the illegally distributed products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the Medical Device Distributing Enterprise License shall be revoked by the authorities which originally issued the license; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 40 In cases where false certificates, documents, materials, or product samples are submitted in registration applications, or obtaining medical device registration certificates are obtained using other deceitful means, which violate provisions of these Regulations, the product registration certificates shall be revoked by the authorities which originally issued the certificates, and within a period of two years, other product registration applications of the violating enterprise shall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; for enterprises already started manufacturing, all of the illegally manufactured products and their illegal incomes shall be confiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 41 Violation of Article 34 of these Regulations concerning provisions for advertisement of medical devices shall be dealt with by the industrial and commercial authority according to relevant laws and regulations of the country.Article 42 In cases of Medical institutions using medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violate provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction, launch a warning, and confiscate all of the illegally used products and illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 43 In cases of medical institutions re-using devices for single use, or not destroying devices which should be destroyed, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 5 thousand to 30 thousand yuan; in serious cases, the medical institutions may be applied with a fine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and other directly responsible personnel be applied with disciplinary punishment; and in case crimes are committed, criminal liabilities shall be investigated and handled according to the law.Article 44 In cases in which medical institutions undertake clinical trials or clinical verifications of medicaldevices and provide false reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RM B 10 thousand to 30 thousand yuan；in serious cases, the qualification for clinical trial or clinical verification of medical devices shall be terminated, person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; an d in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 45 For cases in which testing institutions and their personnel are found to be conducting or involved in research and development, manufacturing, distribution and technical consultation of medical devices which are related to the testing, or establishing false testing reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 10 thousand to 30 thousand yuan; in serious cases, the qualification for testing shall be terminated by the drug regulatory authority under the State Council, person(s) in charge and other directly responsible personnel shall be receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to law.Article 46 In cases where personnel engaged in supervision and administration of medical devices abuse their power, pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of these Regulations, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled according to the law. For those not committing crimes, disciplinary punishment shall be applied according to the relevant regulations.Chapter VI Supplementary ProvisionsArticle 47 Provisions governing non-profitable contraceptive devices shall be formulated separately by the drug regulatory authority in conjunction with other relevant authorities under the State Council.Article 48 These Regulations shall come into force from April 1, 2000.。
医疗器械注册流程 英文专业术语
医疗器械注册流程英文专业术语Medical Device Registration Process: Professional TerminologyIntroductionIn the medical device industry, the registration process is a crucial step for ensuring the safety and efficacy of medical devices before they can be sold on the market. This article will provide an overview of the medical device registration process, including key terms and terminology commonly used in the industry.1. Regulatory AuthorityThe regulatory authority is the government agency responsible for overseeing the registration of medical devices in a particular country or region. In the United States, the Food and Drug Administration (FDA) is the regulatory authority for medical devices. In Europe, the European Medicines Agency (EMA) and the European Commission are responsible for regulating medical devices.2. ClassificationMedical devices are classified into different risk categories based on their intended use and potential risks to patients. The classification of a medical device will determine the regulatory requirements for registration. In the US, medical devices are classified into Class I, II, or III based on risk. In Europe, medical devices are classified into Class I, IIa, IIb, or III based on risk.3. Pre-Market Approval (PMA)Pre-market approval (PMA) is the process by which the regulatory authority evaluates the safety and efficacy of a medical device before it can be marketed. In the US, medical devices that are classified as Class III require PMA before they can be sold on the market. In Europe, medical devices that are classified as Class III also require pre-market approval.4. 510(k) NotificationThe 510(k) notification is a pre-market submission to the FDA that demonstrates a medical device is substantially equivalent to a legally marketed device. If the FDA determines that the device is substantially equivalent, it can be marketed in the US. The 510(k) process is commonly used for Class II medical devices in the US.5. CE MarkingCE marking is a conformity assessment marking that indicates a medical device complies with the essential requirements of European Union directives. In Europe, medical devices must have CE marking before they can be sold on the market. The CE marking process involves conformity assessment by a notified body.6. Quality Management System (QMS)A quality management system (QMS) is a system that outlines the policies, processes, and procedures for ensuring the quality and safety of medical devices. A QMS is required for medical device manufacturers to comply with regulatory requirements. Common QMS standards include ISO 13485 and FDA Quality System Regulation (QSR).7. Post-Market Surveillance (PMS)Post-market surveillance (PMS) is the process of monitoring the safety and performance of medical devices once they are on the market. Manufacturers are required to have systems in place for collecting and analyzing post-market data to identify and address any safety concerns.ConclusionThe medical device registration process is a complex and highly regulated process that requires compliance with regulatory requirements and standards. Understanding the key terms and terminology associated with the registration process is essential for ensuring the safety and efficacy of medical devices for patients. By following the regulatory requirements and implementing a robust quality management system, manufacturers can successfully register their medical devices for sale on the market.。
医疗器械注册管理办法英文版
The Measures for the Administration of Medical Device Registration were passed by State Food and Drug Administration at the administration affairs meeting on May 28, 2004 and are hereby promulgated for implementation as of the date of promulgation.Director general: Zheng XiaoyuAug. 9, 2004Measures for the Administration of Medical Device RegistrationChapter 1. General ProvisionsArticle 1These Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration of medical device registration and guarantee the safety and effectiveness of medical devices.Article 2All the medical devices sold and used within the territory of the People’s Republic of China shall be subject to application for registration in accordance with the provisions of these Measures. The medical devices whose registration fails to be approved shall not be sold or used.Article 3Medical device registration means the process of systematic evaluation of the safety and effectiveness of the medical devices to be sold and used in accordance with the legal procedures to decide whether the sale and use of such medical devices can be approved.Article 4China implements classified registration and administration of medical devices.Category I domestic medical devices are subject to examination by municipal level (food) drug administration authorities of the administrative areas with districts, and medical device registration certificates will be issued after approval by such authorities.Category II domestic medical devices are subject to examination by the (food) drug administration authorities of provinces, autonomous regions and municipalities, and medical device registration certificates will be issued after approval by such authorities.Category III domestic medical devices are subject to examination by the State Food and Drug Administration (SFDA), and medical device registration certificates will beissued after approval by SFDA.Foreign medical devices are subject to examination by SFDA, and medical device registration certificates will be issued after approval by SFDA.Unless otherwise specified hereunder, medical devices from Taiwan, Hong Kong and Macao shall be registered by reference to the measures for the registration of foreign medical devices.The valid period of each medical device registration certificate shall be four years. Article 5Medical device registration certificates shall be printed by SFDA in a centralized way, while the corresponding contents shall be completed by the (food) drug administration authorities responsible for examination and registration.Registration numbers shall be arranged in the following form:×(×)1(S)YJX(×2)Z××××3 No. ×4××5××××6, where,×1 shall mean the abbreviation of the place where the registration examination and approval authority is located:The letter “G” shall be adopted for Category III domestic medical devices, foreign medical devices and medical devices from Taiwan, Hong Kong and Macao;The abbreviation of the province, autonomous region or municipality where the registration examination and approval authority is located shall be adopted for Category II medical devices;The abbreviation of the province, autonomous region or municipality where the registration examination and approval authority is located plus the abbreviation of the local municipal level administrative area with districts shall be adopted in the form of ××1 for Category I domestic medical devices (only the abbreviations of the local province, autonomous region or municipality shall be adopted if there is no corresponding municipal level administrative area with districts);×2 shall indicate the form of registration (Z [approval], J [import] and X [permit]): “Z” is applicable to domestic medical devices;“J” is applicable to foreign medical devices;“X” is applicable to medical devices from Taiwan, Hong Kong and Macao;××××3 shall indicate the year of approval for registration;×4 shall indicate the category of product administration;××5 shall indicate the type code of product; and××××6 shall indicate the serial number of registration.The medical device registration record (see Appendix 1 of these Measures) attached to each medical device registration certificate shall be used together with the medical device registration certificate.Article 6A manufacturer applying for medical device registration shall undertake the corresponding legal obligations and hold a medical device registration certificate after the application is approved.The person handling the matters related to application for medical device registration shall be subject to authorization by the manufacturer, have the corresponding professional knowledge and be familiar with the laws, rules, regulations and technical requirements on the administration of medical device registration.Regarding application for the registration of foreign medical devices, the foreign manufacturer shall designate an organization located within the territory of China to act as the foreign manuf acturer’s agent, who shall undertake the corresponding legal liability. The foreign manufacturer shall also entrust a corporate organization that is located within the territory of China and has the corresponding qualifications or entrust the manufacturer’s organ in China to undertake after-sale service for the medical devices.Article 7The medical device under application for registration shall have an applicable product standard, which may adopt a national standard, a professional standard or a registered product standard formulated by the manufacturer, but the registered product standard shall not be inferior to the relevant national standard or professional standard.Registered product standards shall be formulated in accordance with the requirements of SFDA for the administration of the standards of medical devices.Article 8When a manufacturer applies for the registration of a Category II or III medical device, the manufacturer shall satisfy the production conditions specified by SFDA or meet the requirements of the relevant quality system.Chapter 2. Test for Medical Device RegistrationArticle 9Categories II and III medical devices are subject to registration test by the medical device test organizations recognized by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine. Such medical devices shall be proved conforming to the applicable product standards through test before the medical devices are used for clinical trial or an application is submitted for registration.The list of the medical device test organizations recognized by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine (hereinafterreferred to “medical device test organizations”) will be separately announced.Article 10The medical device test organizations shall conduct registration test to the proposed products and issue test reports within the scope of test approved by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine and in accordance with the product standards proposed by the manufacturers (including the applicable national standards, professional standards or the registered product standards formulated by the manufacturers).For the medical devices that have not been included in the authorized scope of test by the medical device test organizations, the corresponding registration examination and approval authority shall designate a test organization with the necessary test capacity to test such medical devices.The registration test of foreign medical devices shall be conducted in accordance with the Regulations on the Registration Test of Foreign Medical Devices.Article 11The tested products in a same registration unit shall be typical products that can represent the safety and effectiveness of the other products in this registration unit. Article 12The similar products manufactured by a same manufacturer with the same raw materials may not be subject to biological compatibility test during the biological evaluation of the products for re-registration, provided that the production technology and the expected purpose of the products remain unchanged.The similar products manufactured by a same manufacturer with raw materials that have passed biological evaluation may not be subject to biological compatibility test during the biological evaluation of the products for registration, provided that the production technology and the expected purpose of the products remain unchanged or there are no new potential biological risks.Article 13Application for the registration of a Category II or III medical device may be exempted from registration test if this medical device can satisfy all the following conditions:(1)The basic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration are same as those of the manufacturer’s medical device that has already been approved for registration;(2)The manufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality system for medical devices, and the manufacturer can provide a test report recognized by theoriginal production condition examination authority;(3)The medical device under application for registration has seen no changes relatedto safety and effectiveness as compared with the manufacturer’s similar product that has already been approved for registration and has passed registration test, or though there are changes related to safety and effectiveness, the changed parts and the other parts of the product with subsequent changes related to safety and effectiveness have passed test by a medical device test organization;(4)The manufacturer’s similar product that has already been approved forregistration has seen no adverse events during the monitoring of the adverse events of medical devices in accordance with the relevant regulations;(5)The manufacturer’s similar product that has already been approved forregistration has no record of nonconformities as determined by the (food) drug administration authority during selective examination for product quality supervision within one year; and(6)If the medical device under application is a foreign medical device, the sale of themedical device has been approved by the medical device administration authority of the relevant foreign government.Article 14Application for the re-registration of a Category II or III medical device may be exempted from registration test if this medical device can satisfy all the following conditions:(1)The basic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration are same as those of the manufacturer’s medical device that has already been approved for registration;(2)The manufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality system for medical devices, and the manufacturer can provide a test report recognized by the original production condition examination authority;(3)The medical device under application for re-registration has seen no changesrelated to safety and effectiveness as compared with the originally registered product that has passed registration test, or though there are changes related to safety and effectiveness, the changed parts and the other parts of the product with subsequent changes related to safety and effectiveness have passed test by a medical device test organization;(4)The medical device under application for re-registration has seen no adverseevents during the monitoring of the adverse events of medical devices in accordance with the relevant regulations within the valid period of the original medical device registration certificate; and(5)The originally registered medical device has no record of nonconformities asdetermined by the (food) drug administration authority during selective examination for product quality supervision within one year.Article 15An application for the postponement of test may be submitted for large medical devices that have obtained sales approval from the medical device administration authority of the relevant foreign government, have special requirements for the site of installation and are difficult to be tested, and supplementary test shall be conducted for such medical devices after a medical device registration certificate is obtained.For a product that is under application for the postponement of test and has been approved for registration in accordance with the provision of the above paragraph, the manufacturer must complete registration test after the first medical device is imported and before the medical device is put into use. The medical device shall not be used until the end of satisfactory test.Chapter 3. Clinical Trial of Medical DevicesArticle 16Clinical trial documents shall be submitted for application for the registration of Categories II and III medical devices.Clinical trial documents shall be submitted in the manner specified in the Classified Regulations on Clinical Trial Documents for Medical Device Registration (see Appendix 12 of these Measures).Article 17The Regulations on the Clinical Trial of Medical Devices shall be strictly followed for the medical devices whose clinical trial is conducted within the territory of China. Article 18The clinical trial documents for a medical device whose clinical trial is conducted within the territory of China shall include a contract for clinical trial, a plan of clinical trial and a report of clinical trial.When it’s necessary at the (food) drug administration authority’s discretion, the (food) drug administration authority may ask the manufacturer to submit the instructions on clinical trial, the letter of consent to clinical trial and the original record of clinical trial.Chapter 4. Application for and Examination and Approval ofMedical Device RegistrationArticle 19To apply for medical device registration, the applicant shall, according to the classification of medical devices, submit an application to the corresponding (food)drug administration authority in accordance with the provisions of Article 4 of these Measures. The applicant shall complete a written application for medical device registration and submit application documents in accordance with the corresponding requirements of Appendix 2, 3, 6, 8 or 9 of these Measures. The application documents shall be made in Chinese; and the application documents translated on the basis of foreign documents shall be accompanied by the original documents.The manual of medical device submitted by the applicant shall conform to the Regulations on the Administration of the Manuals, Labels and Packing Marks of Medical Devices.The applicant shall be responsible for the truthfulness of all the contents of the application documents submitted by it.Article 20After a (food) drug administration authority receives an application, this authority shall dispose of the application respectively according to the following circumstances: (1)If the matter under application is beyond the limits of the (food) drugadministration authority’s functions and powers, the (food) drug administration authority shall immediately decide to reject the application and notify the applicant to apply to the relevant administration authority;(2)If the application documents have mistakes that can be corrected on the spot, the(food) drug administration authority shall allow the applicant to correct the mistakes on the spot;(3)If the application documents are incomplete or do not meet the requirements offormal examination, the (food) drug administration authority shall issue a notice for the supplementation or correction of documents to the applicant on the spot or within five working days to inform the applicant of all the contents that need to be supplemented or corrected once and for all; the application documents shall be deemed to have been accepted from the date of receipt if the (food) drug administration authority fails to inform the applicant of the contents that need supplementation or correction within the time limit; or(4)The (food) drug administration authority shall accept the application documentsif the application documents are complete and meet the requirements of formal examination or the applicant has submitted all the necessary supplementary or corrective documents in accordance with the requirements.After accepting or rejecting an application for medical device registration, the (food) drug administration authority shall issue a notice of acceptance or a notice of rejection that is affixed with the (food) drug administration authority’s special seal and dated. Article 21After a (food) drug administration authority accepts an application for medical device registration, the (food) drug administration authority shall conduct substantiveexamination of the application and make a written decision on whether to register the medical device under application for medical device registration. If the application is proved conforming to the regulations through examination and registration is approved, the (food) drug administration authority shall issue a medical device registration certificate to the applicant within 10 working days after the written decision of approval is made. If the application is proved nonconforming to the regulations, the (food) drug administration authority shall make a written decision of no registration, indicate the reason and inform the applicant of its right to apply for administrative reconsideration or bring an administrative lawsuit according to law.Article 22The municipal level (food) drug administration authority of an administrative area with districts shall decide to approve registration or not within 30 working days after accepting an application.The (food) drug administration authority of a province, autonomous region or municipality shall decide whether to approve registration or not within 60 working days after accepting an application.SFDA shall decide whether to approve registration or not within 90 working days after accepting an application.If test, expert evaluation or hearing is needed during the examination of an application for registration, the period of test, expert evaluation or hearing shall not be included in the time limit specified in this Article. The (food) drug administration authority shall notify the applicant of the said period needed by writing.Article 23Application for the registration of a foreign medical device that has obtained no foreign sales license for medical devices shall be examined in accordance with the requirements of technical examination for the registration of similar domestic products (See Appendixes 8 and 9 of these Measures for the documents that need to be submitted).Article 24During the technical examination of application documents for medical device registration, if the (food) drug administration authority finds that the manufacturer needs to supplement documents, the (food) drug administration authority shall issue a notice for the supplementation of documents once and for all.The manufacturer shall fully supplement the necessary documents once and for all within 60 working days in accordance with the requirements of the notice. The period used for supplementing materials shall not be included in the time limit for substantive examination by the (food) drug administration authority. The examination shall be terminated if the manufacturer fails to submit supplementary documents within the specified time limit without justified reasons.Article 25In case the examination of application for registration is terminated, the manufacturer shall put forth no new application within six months after the termination.Article 26If the manufacturer has any objection to the content of the notice for supplementing documents, the manufacturer may put forth its written opinions to the (food) drug administration authority within the specified time limit, indicate the reason of objection and provide technical support documents. The (food) drug administration authority shall make a decision after examining the documents submitted by the manufacturer.Article 27The registration units of medical devices shall be divided according to technical structures, performance indexes and expected purposes in principle.Article 28For a medical device that is registered as a component, the applicant shall indicate the name, model and specifications of the product or component recommended for use together with the medical device.The procedures of complete device registration must be gone through for a complete device that is composed of components that have been approved for registration.For a medical device that is registered as a complete device, a list of its major components shall be provided during application for registration. The complete device shall be registered anew after the performance and specifications of a major component are changed.A medical device that is registered as a complete device may be exempted from separate registration provided that the medical device’s components set forth in the column “Performance, Structure and Components of the Product” in the attached table of the registration certificate for the medical device can be separately sold on the condition of no changes in the form of assembly and the expected purpose.Article 29A (food) drug administration authority shall make public the necessary conditions, procedure and time limit for the corresponding medical device registration, a list of all the documents that need to be submitted and a demonstrative text of application in the administration authority’s website and the medical device registration office.Article 30A (food) drug administration authority shall make public the process and the result of examination and approval during the examination of an application for medical device registration. The applicant and the interested party may present their opinions anddefend themselves on the matters directly related to their major interests.Article 31SFDA shall regularly announce in its website the catalogue of the medical devices that have been approved for registration for public consultation.Article 32In case an application for medical device registration directly touches upon the relationship of major interests between the applicant and another party, the (food) drug administration authority shall tell the applicant and the interested party that they have the right to apply for hearing in accordance with laws, regulations and the other regulations of SFDA; during the examination of an application for medical device registration, the (food) drug administration authority shall publicly announce and hold a hearing of the major licensing matters that touch upon public interests at the (food) drug administration authority’s discretion.Chapter 5. Re-registration of Medical DevicesArticle 33If a manufacturer holding a medical device registration certificate needs to continuously sell or use the relevant medical device after the registration certificate expires, this manufacturer shall apply for re-registration within six months before the valid period of the medical device registration certificate expires. If the manufacturer fails to apply for re-registration within the time limit, the product shall be subject to registration test for re-registration.Article 34In case any of the following items in a medical device registration certificate is changed, the manufacturer shall apply for re-registration of the relevant product within 30 days from the date of change:(1)Model;(2)Address of manufacturing site;(3)Product standard;(4)Performance, structure and components of the product; or(5)Indications.Article 35If the category of product administration is changed within the valid period of the medical device registration certificate, the manufacturer shall, according to the category after change, apply to the corresponding (food) drug administration authority for re-registration within six months.Article 36To apply for the re-registration of a medical device, the applicant shall complete a written application for medical device registration and submit the application documents to the (food) drug administration authority in accordance with the corresponding requirements of Appendix 4, 5 or 7 of these Measures.The relevant provisions of Chapter 4 of these Measures shall apply to the procedures of application acceptance, examination and approval for re-registration if such procedures are not separately specified in this Chapter.Article 37A medical device shall not be reregistered in any of the following circumstances:(1)The applicant fails to meet the requirements specified by the (food) drugadministration authority in accordance with SFDA’s relevant regulations at the time of approval for sale;(2)The medical device is obsolete as indicated by the result of reevaluation by SFDA;or(3)The medical device registration certificate for the medical device has beencancelled in accordance with the Regulations on the Supervision and Administration of Medical Devices.Chapter 6. Modification and Re-issuance of Medical DeviceRegistration CertificateArticle 38In case the items in a medical device registration certificate see any of the following changes, the manufacturer shall apply for the modification of medical device registration certificate within 30 days after the date of change:(1)Change of the manufacturer’s name but no change of the manufacturer’s entity;(2)Change of the manufacturer’s registered address;(3)Literal change of the address of manufacturing site;(4)Literal change of product name or trade name;(5)Literal change of model or specifications;(6)Literal change of the name or code of product standard;(7)Change of agent; or(8)Change of after-sale service provider.Article 39To apply for the modification of a medical device registration certificate, the applicantshall complete an written application for the modification of medical device registration certificate and submit the relevant documents and explanations to the original registration examination and approval authority in accordance with the requirements of Appendix 10 of these Measures. The original registration examination and approval authority shall conduct formal examination of the application documents and inform the applicant of all the contents that need to be supplemented or corrected once and for all on the spot or within five working days. A notice of acceptance shall be issued to the applicant if the application documents meet the requirements.Article 40The original registration examination and approval authority shall decide by writing whether to approve the modification or not within 20 working days after accepting the application. If the modification is proved conforming to the regulations through examination, the original registration examination and approval authority shall issue a modified medical device registration certificate and nullify the original one. If the modification is proved nonconforming to the regulations through examination, the original registration examination and approval authority shall decide by writing to reject the application for modification, indicate the reason and tell the applicant that it has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.The modified medical device registration certificate shall adopt the original serial num ber, and the word “Modified” in brackets shall be added at the end of the serial number.The expiry date of the modified medical device registration certificate shall be same as that of the original certificate, and the certificate holder shall apply for re-registration upon expiry of the valid period.Article 41In case a manufacturer’s medical device registration certificate is lost or damaged, the manufacturer shall apply to the original registration examination and approval authority for re-issuance by submitting the relevant documents and explanations in accordance with the requirements of Appendix 11 of these Measures.Chapter 7. Supervision and AdministrationArticle 42The (food) drug administration authorities in charge of examination and approval for medical device registration shall conduct examination and approval in accordance with the specified procedures and decide whether to approve registration or not. Those who approve registration in violation of the regulations shall undertake the relevant administrative liability.Article 43In case a local (food) drug administration authority at municipal level or above of an。
医疗器械注册管理办法中英文翻译
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.四条国家对医疗器械实行分类注册管理。
医疗器械监督管理条例-英文
RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development， production, distribution， use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation。
Article 3 ”Medical devices” as defined by these regulations refers to: any instrument，apparatus， appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve itsprincipal action in or on the human body by means of pharmacology， immunology or metabolism， but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives：1。
医疗器械监督管理条例-英文
RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices， ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development， production, distribution, use， supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation.Article 3 ”Medical devices" as defined by these regulations refers to: any instrument, apparatus， appliance, material， or other article whether used alone or in combination，including the software necessary for its proper application。
医疗器械注册流程 英文专业术语
医疗器械注册流程英文专业术语Medical Device Registration Process。
The registration of medical devices is a crucial step in ensuring the safety and effectiveness of these products for use in healthcare settings. The process involves several key steps and requirements that manufacturers must adhere to in order to bring their products to market. In this article, we will provide an overview of the medical device registration process, including the key terms and requirements involved.1. Definition of Medical Device。
The first step in the registration process is to clearly define the medical device that is being submitted for registration. According to the International Medical Device Regulators Forum (IMDRF), a medical device is defined as an instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purpose(s) of diagnosis, prevention, monitoring, treatment, or alleviation of disease.2. Classification of Medical Devices。
医疗器械注册管理办法英文(四号令)
Provisions for Medical Device RegistrationChapter I General ProvisionsArticle1The Provisions are formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices with a view to standardizing the registration and filing administration of medical device and guarantee the safety and effectiveness of medical devices.Article2All medical devices sold and used within the territory of the People's Republic of China shall comply with the Provisions to apply for registration or conduct filing. Article3Medical device registration refers to approval process conducted by the food and drug regulatory authority upon an application submitted by the registration applicant, follows the legal procedure to decide whether the medical device to be marked can be approved or not based on a comprehensive assessment on research and its result of medical device’s safety and effectiveness.Medical device filing refers to the food and drug regulatory authority files filing materials submitted by the filing applicant for future reference.Article4Registration and filing shall follow the principle of publicity,justice,and equity. Article5Filing administration shall be implemented for Class I medical devices.Registration administration shall be implemented for Class II and Class III medical devices.Filing for Class I domestic medical device,the filing applicant shall submit the filing to the food and drug regulatory authority of the municipality consisting of districts. Class II domestic medical devices shall be inspected by the food and drug regulatory authority of the provinces,autonomous regions,municipalities directly under the central government,and the Registration Certificate for Medical Device will be granted after approval.Class III domestic medical devices shall be inspected by the China Food and Drug Administration(hereinafter referred to as CFDA),and the Registration Certificate for Medical Device will be granted after approval.Filing for Class I imported medical device,the filing applicant shall submit the filing toCFDA.Class II and Class III imported medical devices shall be inspected by the CFDA,and the Registration Certificate for Medical Device will be granted after approval.The medical devices from Hong Kong,Macau and Taiwan shall be registered or filed refer to the imported medical devices.Article6The registration applicant and filing applicant shall launch product to the market in its own name and hold legal liability for the product.Article7The food and drug regulatory authority shall publicize information of medical device registration and filing according to the regulations.The applicant can inquiry the approval process and results,the public can look up approval results.Article8China encourages research and development and innovation of medical devices, conducts special approval procedures for innovative medical devices,contributes to promotion and application for new technology of medical devices and boosts the development of medical device industry.Chapter II Basic RequirementArticle9The applicant or the filing applicant shall establish quality management system related to R&D and manufacture of product,implement it and keep it operates effectively.For domestic products approved by the special approval procedures for innovative medical device apply for the registration application and samples entrusted other manufacturers to produce,the entrusted manufacturers shall have corresponding manufacturing scope;for domestic products not approved by the special approval procedures for innovative medical device apply for registration application,their samples cannot entrust other manufacturers to produce.Article10The person that apply for registration or conduct filing for medical device shall have the corresponding professional knowledge and be familiar with laws,regulations, normative documents and technical requirements regarding to medical deviceregistration or filing administration.Article11The applicants or the filing applicants shall follow the basic requirement for safety and effectiveness of medical device,ensure R&D process are being truthful and standardized,and all the data is true,complete and traceable when they conduct filing or apply for registration.Article12The materials for registration application shall use Chinese.When the application documents are translated from a foreign language,the original documents shall also be provided at the same time.When referring to unpublished literature,the applicant shall provide evidence of owner’s permission to use the information.The applicant shall take fully responsibility for the authenticity of the registration application documents.Article13For imported medical device intended to apply for registration or conduct filing,the applicant or the filing applicant shall get market clearance of the country or region where their registration or manufacturing place located for the medical device.If country or region where the applicant’s or the filing applicant’s registration or manufacturing places located does not administer the products as medical device, the applicant or the filing applicant shall provide relevant supporting documents, including the approval of legal sales issued by the country or region where their registration or manufacturing place located.Article14The overseas applicant or the filing applicant shall conduct relevant business through their representative office located within the territory of China or designate an enterprise located within the territory of China as agent.Besides conduct registration and filing related work,the agent shall be liable for: (1)Contact with corresponding food and drug regulatory authority and the overseas applicant or the filing applicant;(2)Deliver related laws,regulations and technical requirement to the applicant or the filing applicant truly and faithfully;(3)Collect post-market adverse event information of medical devices and feed back to the overseas applicant or the filing applicant,meanwhile,report to relevant food and drug regulatory authority;(4)Collaborate the recall for post-market medical devices,and report to relevant food and drug regulatory authority;(5)Undertake other joint liabilities related to product quality and after-sales service. Chapter III Product technical requirement and Registration TestingArticle15The applicant or the filing applicant shall prepare the product technical requirement of the medical device to be registered or filed.The product technical requirement of Class I medical device shall be submitted to the food and drug authorities during the applicant conducts filing.The product technical requirement of Class II or Class III medical devices shall be checked and approved by the food and drug authorities at the time of registration approval.The product technical requirement mainly includes the performance indices and testing method of the completed medical device,and the performance indices refer to the objective determination of product functionality,security index and other indicators of quality control.The medical device launched in China shall comply with its product technical requirement which was checked and approved for registration or filed already. Article16The registration testing shall be conducted to apply registration for Class II and Class III medical device.The testing institutes of medical device shall conduct registration testing according to product technical requirement.The manufacture of samples for registration testing shall comply with related requirements of quality management system;products tested to be qualified in registration testing can be used for clinical trial or registration application.The filing applicant can submit self-testing report of the product to conduct filing. Article17To apply for registration testing,the applicant shall provide samples,product technical requirement and other technical materials required by the registration testing to the testing institutes.Article18Testing institutes of medical device shall have certain qualifications,perform testing within their specified testing scope and conduct pre-evaluation on the product technical requirement.The testing institutes shall issue the pre-evaluation opinions and the registration testing report of medical device together to the applicant.For the medical devices that have not been included in testing scope of any medical device testing institutes,the related registration authority shall designate a capable testing institute to conduct the testing.Article19The testing products in a same registration unit shall represent the safety and effectiveness of the rest products in this registration unit.Chapter IV Clinical EvaluationArticle20Clinical evaluation of medical device refers to the process that the applicant or the filing applicant validates whether a product can meet the operating requirements or scope of application or not through clinical literature,clinical practice data,clinical trial and other information.Article21Clinical evaluation materials refer to the documents formed by the applicant or the filing applicant during the clinical evaluation.For those required clinical trial,the clinical evaluation materials to be submitted shall include the protocol and the report of clinical trial.Article22It is not necessary to conduct clinical trial for filing Class I medical devices.It is necessary to conduct clinical trial for registration application of Class II and Class III medical devices;however,in any of the following circumstances,the clinical trial could be exempted.(1)With definite operating principle,established design,mature manufacture process;no record for serious adverse event of substantially equivalent medical devices which have been marketed and clinically applied for years;and without changing the conventional purpose of use;(2)The safety and effectiveness of the medical devices can be proven throughnon-clinical evaluation;(3)The safety and effectiveness of the medical devices can be demonstrated through analyzing and evaluating the data obtained from clinical trial or clinical application of the substantially equivalent medical devices.The clinical trial exemption list of medical device shall be formulated,adjusted and published by the CFDA.For products that not listed in the clinical trial exemption listof medical device and can prove themselves to be safe and effective through analyzing and evaluating the data obtained from clinical trial or clinical application of the substantially equivalent medical devices,the applicant can made an explanation at the time of registration application and provide relevant supporting materials. Article23The clinical trial of medical device shall be conducted in a qualified clinical trial institutes according to the requirements of the Good Clinical Practice(GCP)for medical devices.The manufacture of samples for clinical trial shall comply with the quality management system of medical device.Article24The clinical trial of Class III medical devices with higher risk to human body shall be approved by CFDA before execution.The list for Class III medical devices which required getting an approval for conducting clinical trial shall be formulated,adjusted, and published by CFDA.Article25The approval of clinical trial refer to the process that CFDA decides whether the clinical trial can be conducted by making comprehensive analysis on risk level,clinical trial protocol,clinical benefits,risk analysis report and others of medical device to be conducted clinical trial according to the applicant’s application.Article26For applicants need to process the approval of medical device clinical trial, application materials shall be submitted to the CFDA by following the relevant requirements.Article27CFDA shall pass the application materials to the technical evaluation department for medical device in3workdays after they accepted the application for the approval of medical device clinical trial.The technical evaluation department shall complete technical evaluation in40 workdays and CFDA shall make decision in20days afterwards.For those approved to conduct clinical trial,the Permission for Medical Device Clinical Trial shall be issued; for those not approved to conduct clinical trial,the reason shall be stated in written.Article28If supplementary documents are required during the technical evaluation,the applicant shall be informed once of all the supplements and amendments to be made.The applicant shall submit all necessary supplementary materials once within 1year according to the notice of supplements and amendments.The technical evaluation department shall complete the technical evaluation within40workdays from the date of receiving the materials supplemented or amended.Time required by the applicant for supplementing such materials shall not be calculated in the overall evaluation timeline.The technical evaluation department shall terminate evaluation and come up with disapproval suggestion to the food and drug regulatory authority if the applicant fails to submit the supplementary materials within the specified time,and the decision for disapproval shall be made by the food and drug regulatory authority after checked.Article29Under any of the following circumstances,the food and drug regulatory authorities shall revoke the acquired Permission for Medical Device Clinical Trial：(1)There is false content in clinical trial applications;(2)The original approved clinical trial is verified by the latest research for ethical and scientific problems;(3)Other circumstances shall be revoked.Article30The medical device clinical trial shall be implemented within3year after its approval. For those overdue,the original approved document shall be invalidated automatically.For those that are still need to conduct clinical trial,they shallre-submit the application.Chapter V Product RegistrationArticle31To apply for medical device registration,the applicant shall submit and deliver application documents to the food and drug regulatory authority based on relevant requirements.Article32The food and drug regulatory authority shall conduct administrative review onapplication materials after they received applications for medical device registration, and shall take actions respectively according to the following circumstances:(1)Accept registration applications when the application item is within their function and the application materials are complete and comply with the requirements of administrative review;(2)Allow the applicant to correct the application documents on site if possible;(3)Inform the applicants all the content correction to be made for once within five workdays when found the application materials are incomplete or do not meet the requirement of administrative review;if no information are given by5workdays,the application shall be deemed as being accepted since the acceptance date of application materials;(4)Reject the application and notify the applicant immediately if the application is not within their functions；The food and drug regulatory authority shall grant the dated acceptance ornon-acceptance notice affixed with its special seal to indicate them accepting or rejecting to accept the medical device registration application.Article33The administrative department of the food and drug regulatory authority shall forward the registration application to the technical evaluation department within3 workdays from the date of document acceptance.The technical evaluation department of the food and drug regulatory authority shall complete the technical evaluation within60workdays for Class II medical device registration and complete the technical evaluation within90workdays for Class III medical device registration.For those technical evaluations need to hire outside experts,hold joint technical evaluation with drug evaluation department for drug-device combination products, the extra time shall not be calculated in the overall review timeline,and the technical evaluation department shall give a written notice to applicant for needed extra time. Article34The food and drug regulatory authority can retrieve original research materials,and organize inspection for quality management system regarding to product R&D and manufacture during the technical evaluation.The food and drug regulatory authority of the province,autonomous region,and municipality directly under the central government shall conduct the inspection for quality management system of Class II and Class III domestic medical device registration;for Class III domestic medical device,CFDA shall inform thecorresponding food and drug regulatory authority of the province,autonomous region,and municipality directly under the central government to conduct the inspection,and get itself involved if necessary.The food and drug regulatory authority of the province,autonomous region,and municipality directly under the central government shall complete the inspection within30workdays according to relevant requirement.During the technical evaluation for Class II and Class III imported medical device registration,the technical evaluation department of CFDA can inform technical institute of quality management system of CFDA to conduct the inspection when they deem it is necessary,and the technical evaluation department will also participate in the inspection if necessary.The inspection time for quality management system shall not be calculated in technical evaluation time.Article35If supplementary materials are required during the technical evaluation,the applicant shall be informed once of all the supplementary contents to be made by the technical evaluation department.The applicant shall submit supplementary materials once within1year according to the requirements of supplement notice; the technical evaluation department shall complete the technical evaluation within 60workdays from the date of receiving the supplementary materials.Time required by applicant for supplementing such materials shall not be calculated in overall evaluation timeline.If the applicant has any objection to the content of supplement notice,they can propose written suggestion to the technical evaluation department,explain the reason and provide corresponding technical supporting materials.The technical evaluation department shall terminate evaluation and come up with disapproval suggestion if the applicant failed to supplement materials within the specified timeframe,and the disapproval decision shall be made by the food and drug regulatory authority.Article36The food and drug regulatory authority accepting the registration application shall make decisions within20workdays after technical evaluation.Where requirements concerning safety and effectiveness are met,registration shall be approved and the Registration Certificate for Medical Device shall be granted within10workdays after the date in which approval decision has been made,and the checked and approved product technical requirement shall be provided to the applicant as attachment.Forthose registration are not approved,the authorities shall state the reasons in written and inform the applicant that they have right to apply for re-evaluation and administrative reconsideration,or bring up to administrative litigation in accordance with laws and regulations.The validity term of the Registration Certificate for Medical Device is five years. Article37Registered matters of medical device include approval matters and administrative matters.Approval matters include product name,model,specifications,structure and composition,scope of application,product technical requirement, manufacturing address of imported medical device and so on;administrative matters include name and resident of the applicant,name and resident of the agent, manufacturing address of domestic medical device and so on.Article38When the food and drug regulatory authority approves registration for much-needed medical devices which are intended to treat rare disease or deal with unexpected public health emergencies,they can require the applicant to do further completion work after the product launch and specify those requirements in the Registration Certificate for Medical Device.Article39If the accepted registration application has one of the following circumstances,the food and drug regulatory authority shall decide to disapprove application and inform the applicant:(1)The research and its result conducted by the applicant cannot approve the safety and effectiveness of medical device to be sold;(2)The registration application documents are false;(3)The registration application documents have confused or inconsistent contents;(4)The registration application documents have clearly inconsistent contents with those of application items;(5)Other circumstances that the registration application shall be refused.Article40For the accepted registration application,the applicant may,prior to the administrative decision is made,withdrawal the registration application and relevant materials,and give reason to the food and drug regulatory authority who accept the application.Article41For those accepted registration application,if there are evidences providing that the registration application documents is false,the food and drug regulatory authority can suspend the approval.After verification,the food and drug regulatory authority shall determine to continue the evaluation or disapprove registration according to the verification conclusion.Article42If the applicant has any objection to the disapproval decision made by the food and drug regulatory authority,the applicant may put forth re-evaluation application to the food and drug regulatory authority that makes the decision within20workdays after the receipt of the notice of disapproval for registration application.The contents applied for re-evaluation shall be limited to original application and original application documents.Article43The food and drug regulatory authority shall make decision for re-evaluation within 30workdays after accepting the application for re-evaluation and inform the applicant the decision in written.In case the original judgment is affirmed,the food and drug regulatory authority will not accept the secondary application forre-evaluation by the applicant.Article44If the applicant has any objection to the disapproval decision made by the food and drug regulatory authority and has applied for administrative reconsideration or administrative litigation,the food and drug regulatory authority will not accept the re-evaluation application raised by the applicant.Article45In case of loss of the Registration Certificate for Medical Device,the applicant shall publish lost declaration at the media specified by original certificate-granting authority,and apply to original certificate-granting authority for re-granting such certificate after1month of declaration.Original certificate-granting authority shall re-grant the Registration Certificate for Medical Device within20workdays. Article46Where major interest relationship between the applicant and others is directly involved in the application for medical device registration,the food and drugregulatory authority shall inform the applicant and interested party of right to apply for hearing in accordance with laws,regulations and other provisions of CFDA;during the process of evaluating the application for medical device registration,the food and drug regulatory authority shall publicize major approval matters that are deemed to have been involved in public interests and hold a hearing.Article47For medical devices newly invented and not yet listed in the classification catalogue, the applicant can directly apply for Class III medical device registration,or estimate the device classification according to the classification principles and apply for confirmation to CFDA,then apply for registration or conduct filing.For those directly apply for the Class III medical device registration,CFDA shall determine the classification based on its risk level.For domestic medical device confirmed to be Class II medical devices,CFDA shall forward application material to the food and drug regulatory authority of the provinces,autonomous regions, municipalities directly under the central government where the applicant is located and to review and approve.For domestic medical device confirmed to be Class I medical devices,the CFDA shall forward application material to the food and drug regulatory authority of the municipality consisting of districts where the applicant is located to conduct filing.Article48If there is patent dispute happened during the technical evaluation for registration,it shall be disposed regarding to the laws and regulations.Chapter VI Change RegistrationArticle49To change the content for registered Class II or Class III medical device in its Registration Certificate for Medical Device and appendixes,the applicant shall apply change registration to the original registration authority and submit the application materials according to the relevant requirements.If the product name,model,specifications,structure and composition,scope of application,product technical requirement,or manufacturing address of imported medical device changes,the applicant shall apply Change of Approval Matters with original registration department.If the name and resident of the applicant,or the name and resident of the agent changes,the applicant shall apply Change of Administrative Matters with originalregistration department;if the manufacturing address of domestic medical device changes,the applicant shall apply for Change of Administrative Matters after it applied corresponding approvals for manufacture changes.Article50The food and drug regulatory authority shall grant the change documents of medical device registration within10workdays if the materials for the Change of Administrative Matters can meet the requirements.The food and drug regulatory authorities shall inform the applicants all the materials need to be supplemented at once if the materials for the Change of Administrative Matters are not complete or cannot meet the requirements through the administrative review.Article51For the Change of Approval Matters,the technical evaluation department shall focus on evaluating the changed parts and evaluate the product safety and effectiveness after the change.The food and drug regulatory authority accepting the application for the Change of Approval Matters shall organize technical evaluation within the period specified in Chapter V of the Provision.Article52The change documents of medical device registration shall be used in conjunction with its Registration Certificate for Medical Device and their validity period shall be the same.After get the change documents of medical device registration,the applicant can revise product technical requirement,IFU and labels by itself. Article53Where provisions concerning application acceptance and approval procedures for the Change of Approval Matters are not available in this chapter,Chapter V of the Provision shall prevail.Chapter VII Registration ExtensionArticle54Where it is required to extent validity period of the Registration Certificate for Medical Device,the applicant shall apply registration extension to corresponding food and drug regulatory authority6months before the expiration date and submit application documents according to relevant requirements.。
医疗器械注册管理办法中英文翻译
医疗器械注册管理办法中英文翻译Medical Device Registration Administration Measures (English Translation)Chapter 1 General ProvisionsArticle 1 These Measures are formulated in accordance with the relevant laws and regulations of the People's Republic of China in order to strengthen the supervision and administration of medical device registration, ensure the safety and effectiveness of medical devices, and protect the health and safety of patients and users.Article 2 These Measures apply to the supervision and administration of the registration of medical devices and in vitro diagnostic reagents (referred to as "medical devices" hereinafter) within the territory of the People's Republic of China.Article 3 The State Drug Administration is responsible for the supervision and administration of medical device registration nationwide.Chapter 2 Classification and RegistrationArticle 4 The classification of medical devices shall be conducted in accordance with the principles set out in the Regulations for the Supervision and Administration of Medical Devices, and corresponding registration requirements shall be implemented.Article 5 The registration of medical devices shall be implemented in accordance with the principle of "classification, risk-based, and strictcontrol," and shall be classified into three categories: Class I, Class II, and Class III.Article 6 Medical devices of Class I shall be registered with the regulatory authorities at the provincial level. Medical devices of Class II and Class III shall be submitted to the State Drug Administration for registration.Article 7 The applicant for medical device registration shall be the manufacturer or the authorized representative of the manufacturer within the territory of the People's Republic of China.Article 8 The applicant shall submit a registration application to the registration authority in accordance with the requirements specified in the Regulations for the Supervision and Administration of Medical Devices.Article 9 The registration authority shall conduct a review of the registration application. If the application meets the requirements, the registration authority shall issue a registration certificate and enter the relevant information into the national medical device registration information database. If the application fails to meet the requirements, the registration authority shall notify the applicant in writing and explain the reasons.Chapter 3 Clinical EvaluationArticle 10 For Class II and Class III medical devices, clinical evaluation is required as part of the registration process. The clinical evaluation shall be conducted in accordance with the relevant provisions of these Measures.Article 11 The applicant for medical device registration shall submit a clinical evaluation plan to the registration authority. The plan shall includethe objectives, design, subject selection, and evaluation methods for the clinical evaluation.Article 12 The registration authority shall organize experts to review the clinical evaluation plan. If the plan meets the requirements, the registration authority shall approve the plan. If the plan does not meet the requirements, the registration authority shall notify the applicant in writing and explain the reasons.Article 13 The applicant shall conduct the clinical evaluation in accordance with the approved plan. The clinical evaluation shall be conducted in strict accordance with ethical principles and scientific research norms.Article 14 The applicant shall submit a clinical evaluation report to the registration authority upon completion of the clinical evaluation. The report shall include the research data and analysis results in accordance with the requirements specified in the Regulations for the Supervision and Administration of Medical Devices.Chapter 4 Registration Certificate and LabelingArticle 15 After the registration of medical devices is approved, the registration authority shall issue a registration certificate and enter the relevant information into the national medical device registration information database.Article 16 The registration certificate shall indicate the registration number, registration validity period, and other relevant information of the medical device.Article 17 The labeling of medical devices shall comply with the requirements specified in the Regulations for the Supervision and Administration of Medical Devices, and the information on the label shall be accurate and complete.Chapter 5 Supplementary ProvisionsArticle 18 The guidelines, technical specifications, and other supporting documents for the implementation of these Measures shall be formulatedand promulgated by the State Drug Administration.Article 19 These Measures shall be effective as of [effective date], andthe Measures for the Supervision and Administration of Medical Device Registration (Order No. XXX, [year]) issued by the [previous regulator]shall be repealed simultaneously.---医疗器械注册管理办法（中文原文）第一章总则第一条为加强医疗器械注册的监管管理，确保医疗器械的安全有效，保护患者和使用者的健康与安全，根据中华人民共和国相关法律法规，制定本办法。
医疗器械注册管理办法(中英文)翻译
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。