美国fda医疗器械体系法规qsr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
怎样大脸变小脸
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
奶粉比例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
画晴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 过程确认
Subpart H - 验收活动:
画房子简笔画
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
什么犹如什么
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
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
扣肉的家常做法Subpart N –统计技术
820.250 统计技术
Subpart A——总则
Subpart A--General Provisions
Sec.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Ⅰ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 practice (CGMP) requirements are t forth in this quality system regulation. The requirements in this part govern the methods ud in, and the facilities and controls ud for, the design, manufacture, packaging, labeling, storage, installation, and rvicing of all finished devices intended for human u. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwi 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 manufacturer engages in only some operations subject to the requirements in this part, and not in others,
that manufacturer need only comply with tho requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to tho 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 u 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-bad 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 the device provisions of the act or under a biological product licen application under ction 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures t 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 parts of this chapter, the regulation specifically applicable to the device in question shall superde 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 u, 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 ud veral times. When a requirement is qualified by "where appropriate," it is deemed to be "appropriate" unless the manufacturer can document justification otherwi.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 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 otherwi. 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 shall superde any other generally applicable requirements.（c）权限。PART820是在（2转正理由
1U.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下建⽴并发布的。不符合本部分（Part 820）的任何适⽤的规定，依据法令ction 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 ctions 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 renders a device adulterated under ction 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。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ction 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ction 520（f）和本部分（Part 820）的要求，可按本法令ction 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 manufacturer who offers devices for import into the United States refus
es to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpo of determining compliance with this part, it shall appear for purpos of ction 801(a) of the act, that the methods ud in, and the facilities and controls ud for, the design, manufacture, packaging, labeling, storage, installation, or rvicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of ction 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under ction 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ction 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.，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 subject to the requirements of ction 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures t forth in 10.30 of this chapter, the FDA
's 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., 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 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 Food, Drug and Cosmetic Act，如修正的（cs.201-903，52 Stat. 1040 et p.，21 U.S.C. 321-394）。所有法案ction 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 (cs. 201-903, 52 Stat. 1040et q., as amended (21 U.S.C. 321-394)). All definitions in ction 201 of the act shall 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 of a device after it is relead 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 asmbly which is intended to be included as part of the finished, packaged, and 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 a unit, lot, or batch of finished devices can be determined.
（e）设计历史⽂件Design history ）。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 ud 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 pha 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 reco
rd.
（h）设计评审Design review。是指对设计的⼀个⽂件化的、全⾯的、系统的检查，评价其满⾜设计要求，评价其有能⼒满⾜要求，并识别任何问题。
(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 the requirements, and to identify problems.
（i）设备历史记录Device history record（DHR）。成品器械历史记录的汇总。
(i)Device history record(DHR) means a compilation of records containing the production history of a finished device.
（j）Device master record（DMR）。成品器械的程序和规范的汇总。
(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.
（k）建⽴Establish。定义⽂件（书⾯或电⼦的）并执⾏。
(k)Establish means define, document (in writing or electronically), and implement.
（l）成品器械Finished device。设备或其附件，⽆论其是否包装、标识或灭菌，能够满⾜使⽤要求或者说能够实现其功能。
(l)Finished device means any device or accessory to any device that is suitable for u or capable of functioning, whether or not it is packaged, labeled, or sterilized.
（m）Lot或batch。⼀个或多个元件或成品器械，均为同⼀种规格、型号、尺⼨、成分或软件版本，在相同条件下⽣产，满⾜相同的特性和质量要求。
(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 esntially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
（n）执⾏职责的管理者Management with executive responsibility。是组织的⾼级员⼯，他们负有建⽴或更改组织的质量⽅针和质量体系的职权。
(n)Management with executive responsibility means tho nior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.
什么是asp
（o）制造商/组织Manufacturer。是指设计、制造、制作（fabricate）、装配或加⼯成品器械的任何⼈。制造商包括但不仅限于根据合同执⾏灭菌、安装、重新标识、重新制造、重新包装或特定的开发职责的制造商，和执⾏这些职责的国外组织的国内分销商。
(o)Manufacturer means any person who designs, manufactures, fabricates, asmbles, or process a finished device. Manufacturer includes but is not limited to tho who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing the functions.
（p）Manufacturing material。指任何⽤于或⽤于催化制造过程的任何原料或物质，在制造过程中产⽣的伴随的成分或副产品，其在成品器械中/上呈现为残留物或杂质，它不是制造商的设计或意图。
(p)Manufacturing material means any material or substance ud in or ud to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is prent in or on the finished device as a residue or impurity not by d
esign or intent of the manufacturer.
（q）不合格Nonconformity。未满⾜规定的要求。
(q)Nonconformity means the nonfulfillment of a specified requirement.
（r）产品Product。部件、原材料、在制品、成品和返回品。
(r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.
（s）质量Quality。⼀组固有特性满⾜要求的程序，包括安全和性能。
(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-u, including safety and performance.
（t）质量审核Quality Audit。按规定的时间间隙和频率，对制造商的质量体系进⾏系统、客观的检查，以确定质量体系活动及其结果符合质量体系程序，这些程序得到有效执⾏，程序适应质量⽬标的需求。
(t)Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that the procedures are implemented effectively, and that the procedures are suitable to achieve quality system objectives.
