FDA医疗器械质量体系手册
FDA医疗器械质量体系手册
When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation.
当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。
Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation.
附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，FDA认为它们是成品器械因为它们可以使用于或作用于并且销售来为健康相关的目的；并且QS法规要应用When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation.
当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。
Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the
QS regulation.
附件器械[807.20(a)(5)]，诸如
血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，因为它们可以使用于或作用于并且销售来为健康相关的目的，FDA认为它们是成品器械；并且QS法规要应于其生产。同样的，装置或零件包括软件是作为成品医疗器械的附加部分销售的，以增加或补充其性能，也作为附件器械对待。既然医疗器械的附件是作为成品来对待，因而受QS法规制约。
A remanufacturer is any person who processes, conditions, renovates, repackages restores or does any other act to a finished device which has been previously distributed to significantly change the finished device's performance or safety specifications or intended use from that established by the original finished device manufacturer. Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation. These manufacturers shall establish and implement quality systems to assure the safety and effectiveness of the devices that are distributed. Such activities include drafting of master records, rebuilding per the master records, inspection and testing, calibration of measurement equipment, control of components, updating of labeling, processing of complaints, and any other GMP requirement applicable to the activities being performed.
再加工者是对成品器械进行加工、翻新、整修、重新包装修复品或任何其他行为来明显改变该经过销售的由原来的成品制造商所设定的成品器械的性能、安全指标或使用目的的人。再加工者也被视为制造商。同样地，这些制造商要接受ＦＤＡ的检查，并满足医疗器械质量体系规章可适用的要求。这些制造商也应建立和实施质量体系，确保其销售的器械的安全和有效。这样的行动包括器械主记录的起草、对照器械主记录重制造、检查和测试、测量仪器的校准、部件的控制、标签的更新、投诉的处理和其他在其活动中可适用的 GMP 要求。
Remanufacturers are also required to comply with the labeling requirements of 21 CFR 801.1(c). This labeling regulation requires that where the person or manufacturer named on the label of the device is not the original manufacturer, the name shall be qualified by an appropriate phrase which reveals the connection that person has with the device, e.g., remanufactured by XYZ Company.
再加工者同时也被要求遵守联邦法规第21 篇第 801.1（c）节中对标签所作的规定。该标签规章要求器
械标签的制造商名字不是初始制造商，并且名称应选用那些揭示其与器械的关系的合
适的措词，譬如，由某某公司再加工。
Custom Device Manufacturers
定制器械制造商
Se
ction 520(b) of the FD&C Act and the IDE regulation (21 CFR Part 812) define a custom device. Custom devices are exempt from certain statutory requirements. For example, manufacturers of custom devices are not required to comply with premarket approval requirements (Section 515) and are exempt from premarket notification requirements [Section 510(k)]. Custom devices are NOT exempt from the GMP requirements. Current FDA policy, however, is to not inspect manufacturers of custom devices. Manufacturers of custom devices should comply with the GMP requirements while considering the flexibility allowed.
食品、药品和化妆品法的第520（b）节和联邦法规第21篇812.3（ｂ）篇研究用器械豁免（IDE）法规都对定制式器械进行了定义。定制式器械被豁免某些法定的要求。例如，定制式器械制造商不要求遵守上市前批准规定（515节）和免除上市前通告规定［510（k）节］。但是定制式器械没有被豁免GMP要求。定制式器械制造商应顺应 GMP 要求同时又考虑允许的灵活度。
Contract Manufacturers
合同制造商
A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract. Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA. Depending on the circumstances, both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.
合同式制造商是指以合同方式为其他制造商生产成品器械的人（或集体）。制造商间的协议应以书面合同的形式作为凭证。成品器械的合同式制造商应遵从质量体系中可适用的要求，并向FDA 登记其产品。根据情况，FDA 可以要发包人和制造商对所实施的行为承担共同责任。
Contract Testing Laboratories
合同检测实验室
Contract laboratories that designs or test components or finished devices for a manufacturer are considered an extension of the manufacturer's quality system. These laboratories may provide services to a number of customers, many of which are not medical device manufacturers. These contract laboratories are not subject to routine GMP inspections. Through the conduct of quality audits or other means, the finished device manufacturer is responsible for assuring that equipment and procedures used by a lab are adequate and appropriate (820.50). However, an internal test laboratory, if part of a manufacturer that does testing for various facilities within the corporation, is subject to inspection when FDA GMP inspections are conducted at the individual manufacturing
facilities. That is, the test laboratory is simply a part of a medical device manufacturer of which all device-related divisions shall comply with the QS regulation.
根
据制造商的具体要求进行设计或检测部件或成品器械的合同实验室，被当作该制造商质量体系的延伸部分。这些实验室可以向许多客户提供服务，他们中的很多并非医疗器械制造商。这些合同式实验室不必接受GMP的例行检查。通过进行质量审查或其他手段，成品器械制造商有责任确保实验室所用的设备和步骤是适当的和可靠的（820.50 节）。然而，作为企业的一部分，为企业内不同厂家提供测试的内部检测实验室，当FDA对某个单独的生产厂进行GMP检查时，也应将其包括在内。也就是说，检测室是医疗器械制造企业的一部分，而所有与器械相关的部门均应遵守质量体系规章。
Repackagers, Relabelers, and Specification Developers
再包装者、再标识者和技术说明制定者
Repackaging and relabeling of a device and specification development are defined as manufacturing in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers of Devices. Some definitions from 807.3(d) are reprinted below because they affect the applications of the QS regulation.
在联邦法规第21篇第820.3（o）节和第807 篇以及《器械制造商的企业注册与器械列表》中，均将器械的再包装和再标识以及技术说明制定行为定义为制造。下面摘录的是联邦法规21第807.3(d)中的一些定义，因为它们会影响质量体系法规的应用。
(d) "Manufacture, preparation, propagating, compounding, assembly, or processing" of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of a device in section 201(h) of the Act.
“器械的制造、准备、 复制、组合、 装配或加工”指通过化学的、物理的、生物的或其它的方法制造符合《食品、药品和化妆品 法》第 210（h）有关器械定义的任何物品。
These terms include the following activities:
这些术语包括下列的行为：
(1) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;
(1) 重新包装或其它改变任何器械包装的容器、包装材料或标签，以进一步将器械从原始制造地分发到最后的交货或销售给最终用户的人；
(2) Initial distribution of imported devices; or
(2)进口器械的初次销售；或者
(3) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specification
s.
(3) 技术说明制定者制定规格委托第二方根据其设定的技术规格为其制造器械，再由技术规格制定者进行商业销售。
As defined above, repackaging and relabeling are manufacturing operations. F
urther, a repacker, repackager or relabeler is a manufacturer per 820.3(o) and subject to the applicable requirements of the QS regulation. Individuals are repackers or relabelers if they:
根据上面的定义，再包装和再标识是制造行为。这样，再装箱者、再包装者或再标识者都是制造商，均应遵守质量体系法规中适用的要求。符合下列情况的个人是再装箱者或再标识者：
* package and/or label previously manufactured finished devices or accessories;
* receive finished devices in bulk (e.g., surgical tubing, syringes, media, etc.,) and repacks them into individual packages and label them ；
* receive previously manufactured devices that have been packaged and labeled by another manufacturer, and combine them into a kit with other unpackaged devices which are received in bulk.
* 包装或标志已制造的成品器械或附件。
* 批量接收成品器械（如手术用管，注射器，培养 基等）进行再包装成单个包装并标志；
* 接收已由其他制造商包装和标识先前制造 的器械，并把批量收到的未包装的其他器械和其组合成套件。
Individuals are not considered repackers or relabelers or a manufacturer for purposes of applying the QS regulation if they pack only previously packaged and labeled individual devices into packages for the convenience of the user. (Note that this activity is essentially the same as a drug store employee placing packaged items into a bag labeled with the name of the drug store.)
如果个人为了用户使用方便而只把先前包装和标识的器械包装成包，那么他们不被当作适用质量体系规章意义上的再包装者、再标识者或制造商。（注释：这种行为在本质上与药店雇员将已包装的商品放入印有该店名称的包装袋中相同。
A distributor who only adds a label bearing their name and address is exempt from the GMP requirements. A manufacturer simply affixing a sticker label bearing the distributor's name and address would not require record keeping demonstrating compliance with labeling controls requirements.
经销商，如果只将他们的名称和地址添加在标签上，可以豁免 GMP要求。如果制造商仅是简单地把带有销售商名称和地址的粘贴标签贴上，他不需要保留记录来证明其遵守标签控制要求。
Specification developers provide specifications to contract manufacturers, who produce devices to meet the specifications. The contract manufacturer may package and label the device, or the finished device may be shipped to the specification developer for packaging and labeling.
技术规格制定者
把技术规格提供给合同式制造商，由他来生产符合技术规格要求的器械。合同式制造商可以对该器械进行包装和标识，也可以将成品器械运给技术规格制定者让其自行包装和标识。
Specification developers are manufacturers and are su
bject to the GMP requirements that apply to the activities they conduct, such as various design controls including correct transfer of the design information to a contract manufacturer [820.30(h)]. This activity, in turn, requires an adequate device master record (820.181) and adequate change control [820.40(b)]. Further, if the product carries the specification developer's label, the developer is responsible for maintaining a complaint file and processing complaints, plus maintaining the device specifications and other appropriate documents in the device master record.
技术规格制定者属于制造商，应遵守与他们行为相关的GMP要求，如各种设计控制，包括将设计信息准确传递给合同式制造商【830.30（h）】。相应的这种行为需要适当的器械主记录【820.181】和适当的文件变化控制【830.40（b）】。此外，如果产品标识有技术规格制定者的标志，则技术规格制定者应负责保留投诉文件，处理投诉，并在器械主记录中保留器械技术规格和其它有关的文件。
Initial Distributors of Imported Devices
进口器械的初始分销商
The initial distributor is the foreign manufacturer's official correspondent with the FDA. With regards to the GMP, this initial distributor is responsible for maintaining complaint files and general record keeping requirements. A procedure shall be established and maintained for receiving, reviewing, and evaluating complaints. All complaints, including oral complaints, are to be processed in a uniform and timely manner. These complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device Reporting. The initial distributor is also required to evaluate all complaints to determine whether an investigation is necessary, as well as complying with all other requirements in 820.198, Complaint Files. See Chapter 15 in this manual for more complete guidance on handling complaints.
一级经销商是FDA对国外制造商的正式联络人。相关于GMP，该一级经销商应负责建立投诉文档并负责保留通常记录的要求。应建立并维护有关接收、回顾和评估投诉的程序。所有的投诉，包括口头投诉，要以统一的、及时的方式加以处理。应对这些投诉进行评估，并根据医疗器械报告制度（联邦法规21篇804或803部）要求决定它们是否需要向FDA报告。一级经销商应对所有投诉进行评 估来决定是否需要举行调查，同时也要遵守所有其他820.198关于投诉文档的要求。更完整的
处理投诉的指南见本手册第15章