美国FDA医疗器械体系法规QSR820中英文版.docx

1、美国FDA医疗器械体系法规QSR820中英文版美国FDA 医疗器械体系法规QSR820中文版Part 820质量体系法规目录Subpart A- 总则 820.1 范围 820.3 定义 820.5 质量体系Subpart B 质量体系要求 820.20 管理职责 820.22 质量审核 820.25 人员Subpart C- 设计控制 820.30 设计控制Subpart D- 文件控制 820.40 文件控制Subpart E- 采购控制 820.50 采购控制Subpart F- 标识与可追溯性 820.60 标识 820.65 可追溯性Subpart G - 生产和过程控制 820.7

2、0 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确认Subpart H - 验收活动: 820.80 进货、过程和成品器械检验 820.86 检验状态Subpart I 不合格品 820.90 不合格品Subpart J - 纠正和预防措施 820.100 纠正和预防措施Subpart K 标识和包装控制 820.120 设备标签 820.130 设备包装Subpart L 搬运/储存/分销和安装820.140 搬运 820.150 贮存 820.160 分销 820.170 安装Subpart L 记录 820.180 记录的通用要求 820.181 设备主要记录

3、820.184 设备历史记录 820.186 质量体系记录 820.198 投诉文件Subpart M 服务 820.200 服务Subpart N 统计技术 820.250 统计技术Subpart A总则Subpart A-General ProvisionsSec.820.1 范围Sec. 820.1 Scope.（a） 适用性Applicability。（1） 本质量体系法规阐明了当前良好制造法规Current good manufacturing practice（CGMP）的要求。本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施

4、和控制。本标准的目的是保证成品器械的安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适用于所有的医疗器械成品制造商。如果制造商仅从事本部分有要求服从的某些过程而未从事其它过程，则只需符合其实施的过程的要求。对于类设备，设计控制仅适用于Sec.820.30（a）（2）中列出的设备。本法规不适用于成品器械的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血液成分制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。Current good manufacturing

5、practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for hu

6、man use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a m

7、anufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed

8、 in 820.30(a) This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subjec

9、t to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271. .3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under t

10、he device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue

11、practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.（2） 本部分的规定适用于本部分定义的预期用于人体的所有成品器械，不论

12、其在美国(包含:美国任何州或领土,哥伦比亚特区,波多黎各联邦)本土制造还是进口,提供进口的产品。(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia,

13、or the Commonwealth of Puerto Rico.（3） 在本法规中“适用时”（where appropriate）出现过多次。当要求根据“where appropriate”被认为是合格时，其要求应被认为是“适用的”（appropriate），除非组织能提供文件证明其理由。如果不执行预期结果会导致产品不符合其特定的要求，或组织不需要执行任何必要的纠正措施，那么要求就是适用的（appropriate）。(3) In this regulation the term where appropriate is used several times. When a require

14、ment is qualified by where appropriate, it is deemed to be appropriate unless the manufacturer can document justification otherwise. A requirement is appropriate if non-implementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not

15、 being able to carry out any necessary corrective action.（b） 限制。除非特别规定，则本部分质量体系法规是本章其它部分法规的补充要求。在不能符合所有适用的法规，包括本章此部分和其它部分的情况，特别是对讨论中的设备，此法规应取代其它通用要求。(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the

16、event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.（c） 权限。PART820是在（21U.S.C.法令351、352、360、360c、360d、360e、360h、360i、360j、360l、

17、370、374、381、383中）501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并发布的。不符合本部分（Part 820）的任何适用的规定，依据法令section 501（h）条款，可判定该产品为伪劣产品。这类产品及对此不符合负责的任何个人，将依法被起诉。(c)Authority. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704,

18、801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure

19、 to comply, is subject to regulatory action.（d） 外国制造商。如果把器械进口到美国的制造商拒绝允许或同意FDA对其外国工厂履行为确定器械是否符合本法规（Part 820）所进行的检查，可按section 801（a）条款对其提出诉讼。即准备出口到美国的设备，其设计、生产、包装、标签、贮存或服务中使用的方法和设备控制不符合本法令section 520（f）和本部分（Part 820）的要求，可按本法令section 501（h）条款判定在此条件下制造的产品为伪劣产品。(d)Foreign manufacturers. If a manufacture

20、r who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a) of the act, that the me

21、thods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and t

22、his part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.（e） 豁免或特别许可/ Exemptions or variances（1） 任何人希望得到任何医疗器械质量体系要求的豁免或特别许可，应符合法令section 520（f）（2）的要求。根据本章Sec.10.30即FDA行政程序，来提交豁免或特别许可的申请。可以从器械和辐射健康中心和小型制造商援助处获得指导，地址（HFZ-220），1350 Piccard Dr.，Rockvil

23、le，MD20850，U.S.A.，电话1-800-638-2041或1-301-443-6597，传真301-443-8818。(1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted acc

24、ording to the procedures set forth in 10.30 of this chapter, the FDAs administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A.,

25、 telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.（2） 在有关部门确定此种改变符合美国公众健康的最佳利益时，FDA可能发起并同意器械质量体系的特别许可。公在美国公众健康确实需要该设备，且如无此特别许可，则器械就不可能充分有效的生产的情况下，特别许可才有效。(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in

26、 the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.（f） 本部分不适用于本章897部分定义的烟草销售商。Sec.820.3 定义 / Definitions（a） 法案Act。指明Federal

27、Food, Drug and Cosmetic Act，如修正的（secs.201-903，52 Stat. 1040 et sep.，21 U.S.C. 321-394）。所有法案section 201中的定义在本部分法规中均适用。(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-394). All definitions in section 201 of the act shall

28、 apply to the regulations in this part.（b） 投诉Complaint。在设备交付后所有的书面的、电子的或口头的，对设备的标识、质量、耐用性、可靠性、安全性、有效性和性能方面缺陷的信息。(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance

29、 of a device after it is released for distribution.（c） 部件Component。所有意图用来包含成为已完成的、包装、标识的器械的一部分的原材料、物资、构件、零件、软件、固件、连接件、标签或它们的集合。(c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, an

30、d labeled device.（d） 控制号Control number。任何鉴别性符号，如由字母、数字或它们的组合形成的唯一性组合，由控制号可以确定一批或一个器械的制造、包装、标识和交付的历史。(d)Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of

31、 a unit, lot, or batch of finished devices can be determined.（e） 设计历史文件Design history file（DHF）。成品器械的设计历史记录的汇总。(e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device.（f） 设计输入Design input。器械实体和性能要求，是产品设计的基础。(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.（g） 设计输出Design output。是指每个设计阶段和最后所有的设计成果的结果。已完成的设计输出是器械主记录的基础。全部最终完成的设计输出，由器械及其包装和标识和设备主记录组成。(g)Design output means the results of a design effort at each design phase and at the end of the total de