1、Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 1 of 4021 CFR 820Quality System Regulation质量体系手册Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61
2、册，第195号，1996年10月7日 Page 2 of 40Subpart AGeneral ProvisionsA部分 总则820.1 Scope.820.1范围820.3 Definitions.定义820.5 Quality system.质量体系Subpart BQuality System RequirementsB部分 质量体系要求820.20 Management responsibility.管理者职责820.22 Quality audit.质量审核820.25 Personnel. 职员Subpart CDesign ControlsC部分设计控制820.30 Desig
3、n controls.设计控制Subpart DDocument ControlsD部分文件控制820.40 Document controls.文件控制Subpart EPurchasing ControlsE部分 采购控制820.50 Purchasing controls.采购控制Subpart FIdentification and TraceabilityF部分标识和可追溯性820.60 Identification.标识820.65 Traceability.可追溯性Subpart GProduction and Process ControlsG部分生产和过程控制820.70 P
4、roduction and process controls.产品和过程控制820.72Inspection,measuring, and test equipment.检查、测量，测试仪器 820.75 Process validation.过程确认Subpart HAcceptance ActivitiesH部分接收活动820.80 Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则820.86 Acceptance status.接收状态Subpart INonconforming Prod
5、uctI部分不合格产品820.90 Nonconforming product.不合格产品Subpart JCorrective and Preventive ActionReprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 3 of 40J部分纠正预防措施820.100 Corrective and preventive action.纠正预防措施Subpart KLabe
6、ling and Packaging ControlK部分 标签与包装控制820.120 Device labeling.产品标识820.130 Device packaging.产品包装Subpart LHandling, Storage, Distribution, and InstallationL部分操作、存储、分配以及安装820.140 Handling.操作820.150 Storage.存储820.160 Distribution.分配820.170 Installation.安装Subpart MRecordsM部分 记录820.180 General requirements
7、.总要求820.181 Device master record.产品控制记录820.184 Device history record.产品历史记录820.186 Quality system record.质量体系记录820.198 Complaint files.客户抱怨文件Subpart NServicing820.200 Servicing.Subpart OStatistical Techniques820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520,
8、 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart AGeneral Provisions .4 820.1 Scope4Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦
9、注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 4 of 40Subpart AGeneral Provisions 820.1 Scope.820.1范围(a) Applicability. 适用性(1)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 facilities a
10、nd 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 Federal
11、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 those requi
12、rements 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) (2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use
13、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. 在本质量体系法规（QSR）中阐述了 CGMP 的要求。本部分中的要求规定了在下列情况下使用的方法：所有的预期用于人类的最终器械产品的设计、制造、包装、标记、储存、安装和服务中使用的方法。本部分的要求可确保最终器械的安全有效，并符合联邦食品、
14、药品和化妆品法案。本部分内容确定了适用于最终器械的制造商的基本要求。如果制造商从事的一些操作符合本部分的要求，而不是其他部分的要求，则该制造商只需符合那些用于这些操作上的要求。对于 I 类医疗器械，设计控制仅适用于 820.3（a ）（2）部分列出的那些器械。本法规不适用于最终器械的组件和部件的制造商，但鼓励这样的制造商使用本法规中的适宜条款做指南。生产人体血液和血液组件的制造商可不遵守本部分的要求，但要遵守本章 606 的要求。Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules
15、and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 5 of 40(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
16、 of Columbia, or the Commonwealth of Puerto Rico.本部分条款可适用于任何本部分规定的、预期用于人类的最终器械，这样的器械可在美国、哥伦比亚地区和波多黎各共和国生产或进口到这些国家。(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
17、document justification otherwise. A requirement is appropriate if nonimplementation 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.本法规中使用几次词语“适当处”。当一个要求被“适当处 ”修饰时，这一要求就被认为是“适
18、当的” ，除非制造商能以文件的形式提出其它的正当理由。如果不实施某个要求就会导致产品不满足其规定的要求或制造商不能开展必要的纠正措施，则可认为这一要求是“适当的”。(b) Limitations. The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event that it is impossible to comply with all applica
19、ble regulations, both 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.局限性。除非明确声明有其他情况，否则本部分中质量体系法规是对本章其他部分的法规的补充。如果遵守所有适用法规（包括本部分的法规和本章其他部分的法规）是不可能的，则指定应用于讨论中器械的法规应代替其他通用的要求
20、。(c) Authority. 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
21、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 to comply, is subject to regulatory action.Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第
22、195号，1996年10月7日 Page 6 of 40权威性。820 部分内容的是参照权威法案501，502，510，513，514，515 ，518，519，520，522，701，704 ，801，803（21U.S.C.351，352，360，360c,360d,360e,360h,360i,360j,360l,371,374,381,383 ）而制定和发布的。如果器械没有符合本部分的任何适用条款会，按照501法案，可认为该种器械为伪劣产品，造成器械不符合性的人员都要负一定责任。(d) Foreign manufacturers. If a manufacturer who offer
23、s 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 methods used
24、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 this part an
25、d that the devices manufactured at that facility are adulterated under section 501(h) of the act.国外制造商：如果将器械进口到美国的制造商拒绝接受FDA对其国外设施的检查，以确定是否符合本部分801 法案的内容，则可认为生产该器械所使用的方法，设施、设备以及在该场地下生产的、将要进口到美国的器械的设计、生产、包装、标记、贮存、安装或服务不符合520（f）法案和本部分内容的要求，并且按照501（h ）法案的规定，该场地下生产的器械为伪劣产品。(e) Exemptions or variances. 豁
26、免或特殊许可：(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 according to the procedures set forth in 10.30 of this chapte
27、r, the FDAs administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, (HFZ220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 18006382041 or 1301 4436597, FAX 3014438818. （1）任何申请对器械质量体系要求豁免或特殊许可的人员都要遵守
28、法案 520(f)(2)的要求。按照本章 10.30 中阐述的程序要求（ FDA 的管理程序），将豁免或特殊许可的申请提交给FDA。 可从器械与辐射健康中心，小型制造商服务部（ HFZ-220）获得指南。(2) FDA may initiate and 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. Reprinted from the Fe
29、deral Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 7 of 40Such 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
30、 variance. 当代理商确定这样的特殊许可是为了公众健康的利益，FDA可鼓励并允许器械的质量体系要求有一些特殊许可。而且这样的许可只有在保持器械一直有利于公众的健康时才能保持其有效性，在没有特殊许可的情况下不能大量的制造器械。1. 820.3 Definitions.定义(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321394). All definitions in sectio
31、n 201 of the act shall apply to the regulations in this part.法案是指联邦食品、药品和化装品法案。法案中201部分中规定的所有定义都适用于本部分的法规。(b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a
32、 device after it is released for distribution.抱怨：抱怨是指任何以书面、口头、电讯的形式宣称，已放行销售的医疗器械在其特性、质量、耐用性、可靠性、安全性、有效性及性能等方面存在不足的行为。(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, and labeled
33、 device.组件：组件是指任何原材料、物质、零件、部件、软件、固件（软件硬件相结合）、标记或装配件，可作为最终器械、包装器械和标记器械的一部分。(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 a unit, lot, or batch of
34、 finished devices can be determined.控制号码是指任何有特色的符号，如：字母或数字的有特色的组合，或者两者的结合，从中可以确定最终产品批或单元的生产、包装、标记和销售的历史。(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.设计历史文件（DHF）是指记录的汇编，描述了一个最终器械的设计历史。Reprinted from the Federal Register/Vol. 61,
35、No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 8 of 40(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.设计输入是指器械的物理要求和性能要求，其可作为器械的设计基础。(g) Design output means the results of a design e
36、ffort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.设计输出是指每一设计阶段和总体设计的设计努力的结果。最终器械的设计输出是由器械、器械的包装、
37、标签和器械主记录构成。(h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.设计评审是指对设计的形成文件的、全面的、系统的检查以便评价设计要求的充分性，设计满足要求的能力以及识别问题。
38、(i) Device history record (DHR) means a compilation of records containing the production history of a finished device.设备历史记录（DHR）是指包含最终器械生产历史的记录汇编(j) Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.器械主记录（DMR）是指包含最终器械的程序和规范的
39、记录汇编。(k) Establish means define, document (in writing or electronically), and implement.建立是指规定、形成文件（手写的、电子的）和实施。(l) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.最终器械是指任何适于使用或能够运行的
40、器械或器械的附件，无论其是否经包装、标记或灭菌。(m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality
41、within specified limits.Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 9 of 40批是指最终器械、一个或多个组件，其可由唯一的型号、规格、类型、尺寸、结构或软件版本构成，这些器械和组件是在相同的条件下生产的，在规定的范围内有相同的特性和质量。(n) Management with executive responsibility means
42、those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturers quality policy and quality system.有行政职责的管理者是指有权确定质量方针和质量体系或对质量方针和质量体系作出更改的制造商的高级雇员。(o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a fini
43、shed device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.制造商是指任何对最终器械进行设计、生产、制作、组装或加工
44、的人。制造商包括但并不仅仅只限于是那些完成灭菌、安装、重新标记、重新制造、重新包装、制定规范的人，或者完成上述操作的境外初始销售商(p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or
45、 on the finished device as a residue or impurity not by design or intent of the manufacturer.制造材料是指任何使用的材料或物质，这些材料的使用可便于生产加工，或在生产过程中产生的伴随物或副产物，这些物质的是作为残留物或杂质存在于最终器械上，它的产生不是设计出来的，也不是制造商想要的。(q) Nonconformity means the nonfulfillment of a specified requirement.不合格是指不满足规定要求(r) Product means components,
46、manufacturing materials, in- process devices, finished devices, and returned devices.产品是指组件、制造材料、过程中的器械、最终器械和返回器械。(s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for- use, including safety and performance.质量是指器械满足良好使用性能的总体的特性和性能，
47、包括安全和性能。Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations联邦注册局出版，法规与准则，61册，第195号，1996年10月7日 Page 10 of 40(t) Quality audit means a systematic, independent examination of a manufacturers quality system that is performed at defined intervals and at suff
48、icient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.质量审核是指按照规定的时间间隔对制造商的质量体系进行的系统的
49、、独立的检查，以确定质量体系活动和活动的结果符合质量体系程序，并确保质量体系程序得到有效的实施并适合于实现质量体系的目标。(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.质量方针是指与组织质量有关的总的意图和方向，质量方针是由最高管理层制定的。(v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.质量体系是指完成组织的质量管理所需的组织结构、职责、程序、过程和资源。(w) Remanufacturer means any person who processes, conditions,
