新版美国FDA医疗器械标准体系法规QSR中英文版Word格式文档下载.docx

1、 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- 标识和可追溯性 820.60 标识 820.65 可追溯性Subpart G - 生产和过程控制 820.70 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确定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 - 纠正和预防方

2、法 820.100 纠正和预防方法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 统计 820.180 统计通用要求 820.181 设备关键统计 820.184 设备历史统计 820.186 质量体系统计 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 ProvisionsSe

3、c.820.1Sec. 820.1 Scope.（a） 适用性Applicability。（1） 本质量体系法规说明了目前良好制造法规Current good manufacturing practice（CGMP）要求。本标准适适用于全部预期用于人类成品器械设计、制造、包装、标识、储存、安装和服务中所使用管理方法、设施和控制。本标准目标是确保成品器械安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适适用于全部医疗器械成品制造商。假如制造商仅从事本部分有要求服从一些过程而未从事其它过程，则只需符合

4、其实施过程要求。对于类设备，设计控制仅适适用于Sec.820.30（a）（2）中列出设备。本法规不适适用于成品器械部件或零件制造商，但激励这类制造商把本法规合适要求作为指南来使用。人血和血液成份制造商不受本部分法规限制，但应遵照本章606部分法规要求。Current good manufacturing practice （CGMP） requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the fac

5、ilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the

6、 Federal Food, Drug, and Cosmetic Act （the act）. This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with th

7、ose requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in 820.30（a） This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to

8、use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject 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

9、 this chapter, that are medical devices （subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act） are subject t

10、o 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 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 par

11、ts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.（2） 本部分要求适适用于本部分定义预期用于人体全部成品器械，不管其在美国（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,提供进口产品。（2） The provisions of this part shall be applicable to any finished device as defined in this part, in

12、tended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.（3） 在本法规中“适用时”（where appropriate）出现过数次。当要求依据“where appropriate”被认为是合格时，其要求应被认为是“适用”（appropriate），除非组织能提供文件证实其理由。假如不

13、实施预期结果会造成产品不符合其特定要求，或组织不需要实施任何须需纠正方法，那么要求就是适用（appropriate）。（3） In this regulation the term where appropriate is used several times. When a requirement is qualified by where appropriate, it is deemed to be appropriate unless the manufacturer can document justification otherwise. A requirement is if n

14、on-implementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.（b） 限制。除非尤其要求，则本部分质量体系法规是本章其它部分法规补充要求。在不能符合全部适用法规，包含本章此部分和其它部分情况，尤其是对讨论中设备，此法规应替换其它通用要求。（b） The quality syste

15、m regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the 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 shal

16、l 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、370、374、381、383中）501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并公布。不符合本部分（Part 820）任何适用要求，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任何个人，将依法被起诉。（c）Authorit

17、y. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 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

18、renders a device adulterated under section 501（h） of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.（d） 外国制造商。假如把器械进口到美国制造商拒绝许可或同意FDA对其外国工厂推行为确定器械是否符合本法规（Part 820）所进行检验，可按section 801（a）条款对其提出诉讼。即准备出口到美国设备，其设计、生产、包装、标签、贮存或服务中使用方法和设

19、备控制不符合本法令section 520（f）和本部分（Part 820）要求，可按本法令section 501（h）条款判定在此条件下制造产品为伪劣产品。（d）Foreign manufacturers. If a manufacturer 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

20、purpose of determining compliance with this part, it shall appear for purposes of section 801（a） of the act, that the methods 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

21、that are offered for import into the United States do not conform to the requirements of section 520（f） of the act and this part and that the devices manufactured at that facility are adulterated under section 501（h） of the act.（e） 豁免或尤其许可/ Exemptions or variances（1） 任何人期望得到任何医疗器械质量体系要求豁免或尤其许可，应符正当令

22、section 520（f）（2）要求。依据本章Sec.10.30即FDA行政程序，来提交豁免或尤其许可申请。能够从器械和辐射健康中心和小型制造商援助处取得指导，地址（HFZ-220），1350 Piccard Dr.，Rockville，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 subje

23、ct to the requirements of section 520（f）（2） of the act. Petitions for an exemption or variance shall be submitted according 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

24、 Small Manufacturers, International and Consumer Assistance （HFZ-220）, 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.（2） 在相关部门确定此种改变符合美国公众健康最好利益时，FDA可能提议并同意器械质量体系尤其许可。公在美国公众健康确实需要该设备，且如无此尤其许可，则器械就不可能充足有效生产情况下，尤其许可才有效。（2） FDA may initiate an

25、d grant a variance from any device quality system requirement when the agency determines that such variance is in 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 suff

26、iciently available without the variance.（f） 本部分不适适用于本章897部分定义烟草销售商。Sec.820.3 定义 / Definitions（a） 法案Act。指明Federal Food, Drug and Cosmetic Act，如修正（secs.201-903，52 Stat. 1040 et sep.，21 U.S.C. 321-394）。全部法案section 201中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.

27、 201-903, 52 Stat. 1040et seq., as amended （21 U.S.C. 321-394）. All definitions in section 201 of the act shall apply to the regulations in this part.（b） 投诉Complaint。在设备交付后全部书面、电子或口头，对设备标识、质量、耐用性、可靠性、安全性、有效性和性能方面缺点信息。（b）Complaint means any written, electronic, or oral communication that alleges defi

28、ciencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.（c） 部件Component。全部意图用来包含成为已完成、包装、标识器械一部分原材料、物资、构件、零件、软件、固件、连接件、标签或它们集合。（c）Component means any raw material, substance, piece, part, software, fi

29、rmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.（d） 控制号Control number。任何判别性符号，如由字母、数字或它们组合形成唯一性组合，由控制号能够确定一批或一个器械制造、包装、标识和交付历史。（d）Control number means any distinctive symbols, such as a distinctive combination of letters or numbers

30、, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.（e） 设计历史文件Design history file（DHF）。成品器械设计历史统计汇总。（e）Design history file （DHF ） means a compilation of records which describes the design history

31、 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终全部设计结果结果。已完成设计输出是器械主统计基础。全部最终完成设计输出，由器械及其包装和标识和设备主统计组成。（g）Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the dev