TheregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管

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医疗器械分类规则 英文版

医疗器械分类规则 英文版

医疗器械分类规则英文版The Regulatory Framework for Medical Devices: Classification Criteria and ConsiderationsMedical devices play a crucial role in modern healthcare, providing vital tools and technologies to diagnose, treat, and monitor various health conditions. As the medical device industry continues to evolve, the need for robust regulatory frameworks to ensure the safety, efficacy, and quality of these products has become increasingly important. One of the fundamental aspects of medical device regulation is the classification system, which categorizes devices based on their intended use, level of risk, and other relevant factors.The classification of medical devices is a complex and multifaceted process that involves a thorough assessment of the device's characteristics and potential risks. The primary purpose of this classification system is to ensure that appropriate regulatory controls are in place to mitigate the risks associated with each device, thereby protecting patient safety and public health. By categorizing medical devices into different classes, regulatory authorities can tailor the review and approval process, as well as the ongoing monitoring and surveillance requirements, to match the level of risk presented by thedevice.In most regulatory jurisdictions, medical devices are generally classified into three or four main categories, with Class I representing the lowest-risk devices and Class III (or IV, in some cases) representing the highest-risk devices. The specific criteria and rules for device classification may vary across different regulatory frameworks, but the underlying principles and considerations are often similar.One of the key factors in the classification of medical devices is the intended use of the device. Devices that are intended for use in the diagnosis, treatment, or monitoring of a medical condition, or that are intended to modify the anatomy or a physiological process, are typically subject to a more stringent regulatory review than devices that are primarily intended for purposes such as patient comfort or convenience.Another important consideration in the classification process is the level of risk associated with the device. Devices that have a direct impact on the patient's health or that pose a higher risk of harm, such as those that are implanted or that are used in invasive procedures, are generally classified as higher-risk devices. Conversely, devices that have a lower risk profile, such as those used for routine diagnostic tests or that are external to the body, may be classified aslower-risk devices.In addition to the intended use and risk profile, the classification of medical devices may also take into account factors such as the device's level of technological complexity, the duration of use, and the degree of interaction with the human body. Devices that incorporate advanced technologies, have a prolonged period of use, or have a high level of interaction with the patient may be subject to more stringent regulatory requirements.The classification of medical devices is not a static process, as the landscape of medical technology is constantly evolving. Regulatory authorities must continually review and update their classification frameworks to address the emergence of new and innovative devices, as well as changes in the understanding of device-related risks. This dynamic nature of medical device regulation ensures that the classification system remains relevant and responsive to the needs of patients, healthcare providers, and the industry.In conclusion, the classification of medical devices is a critical aspect of the regulatory framework that ensures the safety, efficacy, and quality of these essential healthcare products. By categorizing devices based on their intended use, risk profile, and other relevant factors, regulatory authorities can tailor the review and approval process, as well as the ongoing monitoring and surveillancerequirements, to effectively manage the risks associated with each device. As the medical device industry continues to advance, the classification system must remain agile and adaptable, enabling the timely introduction of innovative technologies while maintaining the highest standards of patient safety and public health.。

2024年全国医疗设备管理新规定英文版

2024年全国医疗设备管理新规定英文版

2024年全国医疗设备管理新规定英文版Title: New National Regulations for Medical Device Management in 2024In response to the growing need for effective medical device management, the government has introduced new regulations that will come into effect in 2024. These regulations aim to enhance the safety and quality of medical devices used across the country.One of the key changes outlined in the new regulations is the requirement for stricter quality control measures for medical devices. Manufacturers will need to adhere to higher standards to ensure that the devices meet safety and performance requirements. This will help prevent potential risks to patients and improve overall healthcare outcomes.Additionally, the regulations will introduce more comprehensive guidelines for the registration and approval process of medical devices.This will streamline the process and make it more efficient, ensuring that only safe and effective devices are allowed on the market.Furthermore, the new regulations will emphasize the importance of post-market surveillance and monitoring of medical devices. This will help identify any issues or safety concerns that may arise after the devices have been put into use, allowing for timely interventions and corrective actions.Overall, the new national regulations for medical device management in 2024 represent a significant step towards ensuring the safety, quality, and effectiveness of medical devices in the country. These regulations will benefit both healthcare providers and patients by improving the overall standards of care and reducing the risks associated with the use of medical devices.。

2024年医疗设备实验室管理条例英文版

2024年医疗设备实验室管理条例英文版

2024年医疗设备实验室管理条例英文版2024 Medical Equipment Laboratory Management Regulations1. Purpose and ScopeThese regulations outline the management requirements for medical equipment laboratories in 2024.2. Definitions- Medical equipment: Devices used for medical purposes, including diagnostic, therapeutic, and monitoring equipment.- Laboratory: Facility where medical equipment is tested, calibrated, and maintained.3. LicensingAll medical equipment laboratories must obtain a license from the relevant regulatory authority to operate.4. Facility Requirements- Laboratories must be equipped with necessary tools and equipment for testing medical devices.- Adequate space and ventilation must be provided to ensure safety and accuracy in testing.5. Personnel- Qualified and trained personnel must be employed to conduct tests and maintain equipment.- Regular training and certification programs must be provided to ensure staff competency.6. Testing Procedures- Standardized testing procedures must be followed to ensure consistent and reliable results.- Testing protocols must be documented and easily accessible for reference.7. Quality Control- Laboratories must implement quality control measures to monitor the accuracy and reliability of testing.- Regular audits and inspections must be conducted to ensure compliance with regulations.8. Record Keeping- Detailed records of all testing activities, results, and equipment maintenance must be maintained.- Records must be kept confidential and stored in a secure manner.9. Reporting- Test results must be reported accurately and promptly to relevant stakeholders.- Any deviations or abnormalities in test results must be documented and reported to management.10. Compliance- Laboratories must comply with all applicable laws, regulations, and industry standards.- Non-compliance may result in fines, suspension of license, or other penalties.11. AmendmentsThese regulations may be amended as necessary to reflect changes in technology or industry best practices.12. EnforcementRegulatory authorities have the power to enforce these regulations and take appropriate action against non-compliant laboratories.13. Effective DateThese regulations will come into effect on January 1, 2024.14. ConclusionThe 2024 Medical Equipment Laboratory Management Regulations aim to ensure the quality and reliability of medical device testing through standardized practices and compliance with regulatory requirements.。

医疗器械召回管理办法(英文版)12

医疗器械召回管理办法(英文版)12

Ministry of Health of People’s Republic of ChinaOrdinance No.The Regulation of Medical Devices Recall Administration (Test) was approved by the Conference of Ministry of Health on June 28th 2010, and will be activated on July 1st 2010.The Regulation of Medical Devices Recall Administration (Test)Chapter 1General GuidelineArticle 1For better supervision of Medical Devices, to guarantee people’s health and well-being, according to The Administration of Medical Devices, and State Council: About the Special Rules for the improvement of Food and Food Safety, this legislation is drafted.Article 2This regulation applies to Medical Devices sold within PRC.Article 3The definition of Medical Devices recall refers to the actions taken to eliminate the defects of the already sold devices, such as warning, checking, re-labeling, fixing, amending, and completing user’s guides, software updating, replacing, recalling, and destroying of a certain line or model.Article 4The defects mentioned above refers to the medical devices that may be of unreasonable safety or health hazards to people when operated under normal conditions.Article 5The major force of the controlling and eliminating of defective products are the manufacturers of medical devices, therefore these companies are to take full responsibilities for the safety of their products.Article 6Under this regulation, the medical devices’ manufacturers are to establish and perfect their recalling system, to collect the related information regarding the safety of their medical devices, and to investigate, estimate their possible defective products, in order to recall these defective medical devices promptly.Companies that run business with or make use of the medical devices are obliged to assist with the recalling of the medical devices, and informing feedbacks on the recalling information, controlling and reclaiming the defective medical devices strictly according to the recalling regulation.Article 7On condition that companies that run business with or make use of the medical devices discover the medical devices they possess are defective items, the usage and marketing of these products are to stop immediately, while they should inform the manufacturing and supplying parties of these certain products, and report to the Food and Drug Administration and Supervision Department where they belong to; the organizations making use of these devices are also to report to the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government.After receiving the reports from these companies, the Administration Department should notify the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government of the manufacturing company.Article 8For the manufacturers that are having their devices called back, the appointed agencies in China of the imported medical devices manufactured over-seas are under the administration of Health Administration of the province, Autonomous Region or Municipality directly under the Central Government, and they are in charge of the reclamation of these devices, and the other provinces and regions equivalent to it should provide with assistance, c ooperate this region with the reclamation and the related work.The SFDA is in charge of the management of recalling of medical devices national-wide.Article 9SFDA and local administration departments should setup an open system for the recalling of medical devices, for the prompt sharing of information among health administrations of the equivalent level, so that effective measures can be taken leading to the publication of the information and reclamation of the defective devices to the society.Chapter 2Investigation and Evaluation of Defective Medical DevicesArticle 10The manufacturers are to establish and perfect the quality management controlling system, and the supervision system in times of defective incidents, to report, collect the information regarding the quality problems and harmful evens. And investigate and evaluate the possible defects of medical devices.Companies that run business with or make use of the medical devices should cooperate with the manufacturers to investigate and provide necessary documents of the defective products.Article 11The manufacturers should promptly collect and report to the administration departments r egarding the defective events, and the administration departments c an estimate and investigate the possible defective events, and the companies that run business with or make use of the medical devices should provide assistant.Article 12The evaluation of defective devices mainly includes:1.Whether a malfunction or harm has occurred during usage;2.Whether there will be possible harms when used under current conditions,and whether the causes of such harms can be explained by the scientific papers, researches, or relevant exams;3.The features of the regions and its people involved where the harmsoccurred;4.The degree of harms done to people’s health;5.The occurring ratio of such harms;6.The short and long term results of such harms;7.Other possible factors that could bring harm to people.Article 13According to the seriousness of the defective devices, they are categorized into:1.Level one recall: serious harms to health may or have already occurred usingthis certain medical device;2.Level two recall: reversible harms to health may or have already occurredusing this certain medical device;3.Level three recall: the possibility of harmful events occurring is minimalusing this certain medical device, but still it needs to be called back.The manufacturers need to organize and carry out the recalling system scientifically according to the categories of the seriousness of defects, and the sales and usage of the devices.Chapter 3Active RecallArticle 14According to Article 10, 12, after the investigation and evaluation of the medical devices, and certify that these are defective devices; decisions of recalling should be made immediately.When device-recalling occur overseas, the overseas manufacturers of imported medical devices should notify their appointed Chinese agencies and report to the SFDA promptly; when such actions occur in China, the appointed Chinese agencies should carry out the details according to this regulation.Article 15For the decisions made to recall the medical devices, notices have to be sent to the related companies or individuals that run business with or make use of the medical devices. Level one is within 1 day, level two is within 3 days, and level three is within7 days.The recalling notice at least contain the following contents:1.The names, batch information of the recalled medical devices;2.The reason for the call back;3.The requirement of the recall: such as to suspend the sales and usage of theseproducts, forward the recall notice to the related operating and using companies;4.The processing measurements of these recalled products.Article 16Decisions upon the recall of the medical devices by the manufacturers should be formally notified to the Food and Drug Administration Department of the province, autonomous region or municipality directly under the Central Government, and a Report of Device recalled incidents should be filled in 5 days. (See Appendix 1), and a report and proposal of investigation and evaluation should be handed in to the Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government for record.Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government should report promptly to the SFDA in case of level one events occurring.Article 17The investigation and evaluation report should include the following information:1.Detailed information of the recalled medical devices, including basicinformation such as their names and batch;2.The reason for the recall;3.The result of the investigation and evaluation;4.Level of recall;5.Measures to be taken for after the recalling of the medical devices.Article 18Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government can have experts evaluate their proposal of the recall according to practical situation. If the proposal is considered ineffective of the elimination of the defects, manufacturers should be ordered to upgrade the recall level, expend the recalling range, shorten recalling time or alter the measures to be taken for more effective ones.Article 19For decisions made by the manufacturers to alter the recalling proposals that are already reported, a back-up record should be proposed promptly to the Food and Drug Administration.Article 20During the recall procedure of the medical devices manufacturers, a Report of the Enforcement of recall schedule should be sent regularly to the Food and Drug Administration. (See Appendix 2) It is to report the actual enforcement of the proposal.Article 21Detailed records should be kept for the handling of recalled medical devices, and to report to the Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government where the manufacturers are located. As for the defects that can be eliminated by means of warning, checking,s guide, update its software, fixing, relabeling, or amending the devices’ u ser’replacement or destruction, such measures a re be taken where the manufacturer is located. If in need of destruction, such measures should be taken under the supervision of the local Food and Drug Administration.Article 22After completing the recalling of medical devices, result evaluation should be carried out, and a summary report should be submitted to the Food and Drug Administration within 10 days.Article 23Investigations by the Food and Drug Administration Department should start within10 days after receiving the summary report to evaluate the effects of the recall. Conclusions of the investigation and evaluation should be sent formally to the manufacturers and copied to the parallel leveled Health Administration Department.If the elimination of the defects is still considered ineffective after the investigationand evaluation, manufacturers should be required to reprocess the recalling procedure under the command of the Food and Drug Administration Department.Chapter 4Mandatory RecallArticle 24After the investigation and evaluation of the Food and Drug Administration Department, if the defects referred to in Article 4 still exist, and Active Recall nevertook place actively by the manufacturers, mandatory recall are to be activated.Food and Drug Administration Department should require the immediate suspension of sales and usage of the devices.Article 25A notice should be sent to the manufacturers or the appointed Chinese agencies o f imported manufacturers when decision of mandatory recall is made. The notice should include the following information:1.Detailed information of the recalled medical devices, including basicinformation such as the names and batch;2.The reason for the recall;3.The results of the investigation and evaluation;4.The requirements of the recall, including its extent and time limit.Article 26Upon receiving the notice of the recall, the manufacturers of medical devices should formulate, submit and help carry out the recalling proposal, as well as inform the companies or individuals that run business with or make use of the medical devices according to Article 15 and 16.Article 27The manufacturers should report the recall related matters to the Food and Drug Administration Department according to this regulation Article19, 20, 21, 22, and handle the follow-up pressures.The Food and Drug Administration Department should investigate the report according to Article 23, evaluate the result of the recall, and report to the Health Administration Department of parallel level. After the investigation and evaluation, if there are still defects that are considered not effectively eliminated, a new recall should be activated accordingly by the Food and Drug Administration Department.Chapter 5Legal ResponsibilitiesArticle 28If defects of marketed devices are confirmed by the Food and Drug AdministrationDepartment due to violation of law, regulations or rules, administrative sanctions upon the manufacturers should take place in accordance of the law or regulation. For the companies actively eliminate or alleviate the harms occurred, a lesser or reduced punishment should be taken into action in accordance t o the Law of Administrative Penalties; if the illegal activities are minor and are corrected promptly, with no harms done, they can go unpunished.No exemptions of other legal responsibilities should occur when the manufacturers are to recall their medical devices.Article 29In violation of this regulation such as, the manufacturers not actively recalling the devices when defects are detected, mandatory measures are to activate, with a penalty of 3 times the price of the supposed to be recalled devices; in case of serious consequences, the certificate for medical device should be revoked by the original authorization department, until the revocation of medical device registration record.Article 30In violation of Article 24, the manufacturers refuse to recall the devices, a penalty of 3 times the price of the supposed to be recalled devices is to be charged; in case of serious consequences, t he certificate for medical device should be revoked by the original authorization department, until the revocation of medical device registration record.Article 31In case of any circumstances listed below, the manufacturers should receive warning, be granted a time limitation for the amendment, and be punished with a penalty of no more than 30,000 RMB;1.In violation of Article 15, a recalling notice of the medical devices is notforwarded to the companies or individuals that run business with or make use of the medical devices within provided time limit;2.In violation of Article 18, section 2 of Article 23, section 2 of Article 27, nocorrection or recalling measures a re taken according to the regulations of Food and Drug Administration Department;3.In violation of Article 21, no detailed records of the handling of the recalleddevices are kept, or not reporting to the Food and Drug Administration Department.Article 32The manufacturers should receive warning, mandatory correction order in case of the occurrence of circumstances below, and for the ones not corrected after the time limitation, a penalty of no more than 30,000RMB should be charged.1.Not establishing the recalling system according to this regulation;2.Refusing to assist with investigation of the Food and Drug AdministrationDepartment;3.Not submitting the Report of Device recalled incidents, recalling scheduleand investigation evaluation, the enforcement and summary of the recall of medical devices;4.Modification of the recall schedule, but not yet reported to Food and DrugAdministration Department.Article 33Companies dealing and operating the medical Devices in violation of Article 7, section 1, will be forced to cease the selling or using the defective devices, and will be fined a penalty of over 1,000 and no more than 30,000 RMB; if caused serious consequences, their medical devices business certificate will be suspended b y the authorization department.Article 34For companies dealing and operating the medical Devices that refuse to cooperate with the detection of the defects, or assist the manufacturing company with the recall of the devices, a warning of immediate correction will be given; if not, a fine of no more than 30,000 RMB will be charged.Article 35Employees at the Food and Drug Administration Department in violation of their duties or abuse their authorities, will take equivalent punishment.Chapter 6Supplementary ArticlesArticle 36On condition that the medical device to be recalled has already been planted into the patient, the manufacturing company should reach an agreement with the medical institution according to the various reasons, and purpose a solution.Article 37The patients can claim for damages caused by the medical devices from the manufacturing, dealing or operating companies. The dealing and operating companies have the right to pursue compensation from the manufacturing company after granting their compensation to the patients.Article 38This regulation takes effect since July 1st, 2011.Appendix: 1. Report of Device recalled incidents2. Report of the Enforcement of recall scheduleReport of Device recalled incidentsProduct Name Registration Certificate No.ManufacturerChinese Responsible PartiesContact infoRecall events Contact infoUsage range of ProductRelated ProductsRegion and Countries involvedModal/SpecificationRelated ProductsQuantity of Sold Products Quantity (or imported)Identification Information(batch)Reason for recall(brief)Recall Action(brief)Report company:(stamp)Responsible person(Signature)Reporter:(Signature)Date of Report:Report of the Enforcement of recall scheduleProduct name Registration Certificate No.ManufacturerChinese Responsible Parties Contact infoRecall events Contact infoNConsignee Responsible forRecalled Products Number of people should be NotifiedO Number of already Notified T Time of NoticeF Means of NoticeCOther Consignee Number of people should be NotifiedA Number of already NotifiedT Time of NoticeION Means of NoticePerformanceQuantity to be RecalledCompleted QuantityEffectiveness inspectionprocessing methodEstimated Amount of TimeOthersReport company:(stamp)Responsible person(Signature)Reporter:(Signature)Date of Report:。

2024年医疗器械安全监管条例英文版

2024年医疗器械安全监管条例英文版

2024年医疗器械安全监管条例英文版Title: Regulations on Medical Device Safety Supervision in 2024In 2024, new regulations on medical device safety supervision will be implemented to enhance the quality and safety standards of medical devices. These regulations aim to protect public health and ensure that medical devices meet the necessary safety requirements.The regulations will cover various aspects of medical device safety, including manufacturing standards, quality control measures, post-market surveillance, and reporting of adverse events. Manufacturers will be required to comply with these regulations to ensure that their products are safe for use by patients.Additionally, the regulations will establish a framework for regulatory authorities to monitor and supervise the safety of medical devices in the market. This will involve conducting regular inspections,audits, and reviews of manufacturers to ensure compliance with safety standards.Furthermore, the regulations will include provisions for the reporting of adverse events related to medical devices. Manufacturers, healthcare providers, and patients will be required to report any incidents of device malfunction, injury, or death to the regulatory authorities for investigation.Overall, the regulations on medical device safety supervision in 2024 will play a crucial role in ensuring the quality and safety of medical devices in the market. By upholding stringent safety standards and regulatory oversight, these regulations will help protect patients and promote public health.。

gbz医疗器械融入法规要求的指南

gbz医疗器械融入法规要求的指南

gbz医疗器械融入法规要求的指南英文回答:The integration of medical devices into regulatory requirements is essential to ensure their safety and efficacy in the market. This process involves adhering to guidelines and regulations set by governing bodies to ensure that the medical devices meet the necessary standards.One important guideline for medical device integration is the Good Manufacturing Practices (GMP) requirements. These requirements outline the necessary procedures and controls that manufacturers must follow during the production process. This includes aspects such as facility design, equipment validation, personnel training, and quality control measures. By adhering to GMP requirements, manufacturers can ensure that their medical devices are produced in a consistent and controlled manner, reducing the risk of defects or malfunctions.Another key guideline is the ISO 13485 standard, which focuses on the quality management system for medical devices. This standard sets out the requirements for the design, development, production, and distribution of medical devices. By complying with ISO 13485, manufacturers can demonstrate their commitment to quality and ensure that their devices meet the necessary regulatory requirements.In addition to these guidelines, medical device manufacturers must also comply with specific regulations set by regulatory bodies, such as the Food and Drug Administration (FDA) in the United States or the European Union's Medical Device Regulation (MDR). These regulations outline the necessary steps and documentation required for the approval and marketing of medical devices. This includes conducting clinical trials, obtaining necessary certifications, and maintaining post-market surveillance.Overall, the integration of medical devices into regulatory requirements is crucial to ensure their safety and effectiveness. By following guidelines such as GMPrequirements and ISO 13485, manufacturers can demonstrate their commitment to quality and compliance. Additionally, adhering to specific regulations set by governing bodies ensures that medical devices meet the necessary standardsfor approval and marketing.中文回答:将医疗器械融入法规要求是确保其在市场上的安全性和有效性的关键。

澳大利亚医疗器械监管概述

澳大利亚医疗器械监管概述

澳大利亚医疗器械监管概述1 澳大利亚的医疗器械管理机构澳政府于1990 年正式成立了治疗品管理局(TGA,Therapeutic Goods Administration),管理药品、医疗器械以及其它治疗品,直属联邦卫生和老龄部(Commonwealth Department of Health and Ageing)。

TGA 通过开展一系列的评审和监督管理活动,确保澳大利亚可用的治疗品符合合适的标准,旨在保证澳大利亚社会的治疗水平在合理的时间内得到发展。

TGA 下设9 个部门,分别是事业管理组(Business Management Group)、行政支持组( Executive Support Uni t)、辅助药品办公室(Office of Complementary Medicines)、器械、血液和组织办公室(Office of Devices, Blood and Tissues)、实验室和科学服务办公室(Offce of Laboratories and Scientifc Services)、制造质量办公室(Offce of Manufacturing Quality)、药品安全监管办公室(Offce of Medicines Safety Monitoring)、非处方药办公室(Offce of Non Prescription Medicines)和处方药办公室(Offce of Prescription Medicines)。

由器械、血液和人体组织办公室(ODBT) 通过上市前评价,发放生产许可证和上市后警戒控制医疗器械的管理。

2 法律法规澳大利亚早在1966年就开始使用《医疗用品法案1966))对医疗用品(包括化学药品、生物制品、医疗器械、草药制品、维生素及矿物质)进行管理。

《医疗用品法案1989)>是目前对医疗用品进行管理的主要法案,目的是为规定如何保证澳大利亚医疗用品的质量、安全性及有效性提供一整套全国性的方案。

英国医疗器械法规

英国医疗器械法规

英国医疗器械法规(实用版)目录1.英国医疗器械法规简介2.英国医疗器械法规的分类3.英国医疗器械法规的执行机构4.英国医疗器械法规的法规要求5.英国医疗器械法规的合规方式6.英国医疗器械法规的违规处罚7.我国医疗器械企业在英国市场的应对策略正文【英国医疗器械法规简介】英国医疗器械法规是指在英国境内生产、销售和使用的医疗器械所需遵守的相关法律法规。

这些法规旨在确保医疗器械的安全性、有效性和质量,以保护公众的健康和安全。

【英国医疗器械法规的分类】英国医疗器械法规主要分为以下几类:1.欧盟指令:英国作为欧盟成员国,需遵守欧盟有关医疗器械的指令,如欧盟医疗器械指令(MDD)和欧盟主动植入式医疗器械指令(AIMDD)等。

2.英国法规:英国政府根据欧盟指令制定了一系列国内法规,如《医疗器械法规》(The Medical Devices Regulations,简称 MDR)和《主动植入式医疗器械法规》(The In-vitro Diagnostic Medical Device Regulations,简称 IVDR)等。

3.标准和指南:英国标准协会(BSI)等机构发布了一系列医疗器械相关的标准和指南,如 BS EN ISO 13485《医疗器械 - 质量管理体系 - 要求和指南》等。

【英国医疗器械法规的执行机构】英国医疗器械法规的执行机构主要包括:1.英国药品和保健产品监管局(MHRA):负责医疗器械的监管,包括产品注册、上市后监管、合规检查等。

2.英国标准协会(BSI):负责医疗器械标准的制定和推广。

3.英国国家医疗服务体系(NHS):负责医疗器械在国家医疗服务体系中的采购和使用。

【英国医疗器械法规的法规要求】英国医疗器械法规对医疗器械的生产、销售、使用等方面提出了一系列要求,包括:1.注册:大部分医疗器械需要在 MHRA 进行注册,部分高风险医疗器械还需通过认证机构的认证。

2.合规评估:医疗器械企业需进行合规评估,确保产品符合法规要求。

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Tens of thousands of hip and knee procedures are performed every year. Ongoing safety and
performance monitoring is important to ensure public safety after the device is made
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2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Hip procedures performed 2002 - 2012
alleviation of disease, injury or disability • investigation, replacement or modification of the
anatomy or of a physiological process • control of conception
Glucose meter
no public health risk or low personal risk
Class 2 IVD or Class 2 in-house IVD: low public health risk or moderate personal risk
Pregnancy and fertility self-testing kits
45000 40000 35000 30000 25000
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20000
15000
10000
5000
0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
real life use
6
Benefit versus risk approach
The level of regulation is based on consideration of:
Risk to patients, users and other
persons (probability and severity of harm)
3
What is a medical device?
The TGA defines a medical device as an instrument apparatus, appliance, material or other article intended to be used for human beings for: • diagnosis, prevention, monitoring, treatment or
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available on the market.
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How does a medical device get to market?
A sponsor makes an application to include a device on the Australian Register of Therapeutic Goods (ARTG) so that it can be legally supplied in Australia
See the following slide for an example
11
Assessing benefits versus known side effects
Left ventricular assist device
Complex medical devices used to assist with the ventricular flow of blood to the body in patients with significant heart failure
General principles
• Use of medical devices not to compromise health and safety • Design and construction of medical devices to conform to safety
principles • Medical devices to be suitable for intended purpose • Long-term safety • Medical devices not to be adversely affected by transport or storage • Benefits of medical devices to outweigh any side effects
The applicant must have information available to demonstrate the quality, safety and performance of the medical device
The device must undergo a Conformity Assessment* procedure and comply with the Essential Principles*.
Information on their performance and safety is important prior to market authorisation
Most new devices are
improvements of older
versions based on
data collected from
medical devices • How does a medical device get to
market? • The benefit versus risk approach
• Risk classification rules • In vitro diagnostic tests • Essential principles • Conformity assessment • Safety and performance • Other education modules
• Blood bags • Biological heart valves • Implantable pacemakers
8
In vitro diagnostic tests
In vitro diagnostics have been regulated since July 2010 – with a four year transition period. By the end of the transition period (2014) all IVDs will be regulated to protect public and personal health
2
Comparing medicines and medical devices
A medical device does not achieve its principal intended action by pharmacological,
immunological or metabolic means like a medicine or vaccine
Class 4 IVD or Class 4 in-house IVD: high public health risk
All tests used by the Australian Red Cross Blood Service for the testing of blood
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Essential principles that govern devices
Class 3 IVD or Class 3 in-house IVD: moderate public health risk or high personal risk
Viral load and genotyping assays for HIV and Hepatitis C
Higher risk
Degree of invasiveness in the human body
Intended use of the device
Risk classification is based on:
Duration of use
A device may be selected for review by the TGA once it is on the market. More information and case studies are in the educational module on postmarket monitoring. 7 7
Bandages
Dental implant Breast implant Glucose monitor
4
Many patients require medical devices
60000 50000 40000 30000 20000 10000
0
Knee procedures performed 2002 - 2012
Risk classification rules – medical devices
Lower Medical device classification risk
Example
• Class I
• Class Is (intended to be supplied sterile)
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