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 820.70 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: 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 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 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 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 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 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 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 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 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 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, 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 requirement 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 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 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、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, 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 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 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 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 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.，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 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 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（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 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 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, 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 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 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.（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 these 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 use 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 essentially 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 those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturers quality policy and quality system.（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, assembles, or processes a finished 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.（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 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 on the finished device as a residue or impurity not by design 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-use, 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 manufacturers 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 these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.（u） 质量方针Quality policy。由制造商的最高管理者发布的组织总的质量宗旨和方向。(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.（v） 质量体系Quality system。质量管理的组织结构、职责、程序、过程和资源。(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.（w） Remanufacturer。指对成品器械进行处理、修整、修复、重新包装、恢复或其它活动的人，使成品器械的性能、安全规范或预期用途产生重大更改。(w)Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished devices performance or safety specifications, or intended use.（x） 返工Rework。为使不合格品在其交付前符合DMR的要求而采取的措施。(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.（y） 规范Specification。产品、过程、服务或其它活动应符合的要求。(y)Specification means any requirement with which a product, process, service, or other activity must conform.（z） 确认Validation。通过检查和提供客观证据证明满足预期用途的要求。(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.（1） 过程确认Process validation。根据客观证据确定过程可持续产生满足预先确定规范的结果或产品。(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.（2） 设计确认Design validation。根据客观证据确定设备规范符合使用者的需求和预期用途。(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).（aa） 验证Verification。通过检查和提供客观证据证明满足规定的要求。(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec.820.5 质量体系/ Quality system.制造商应建立并实施适应特定的医疗器械设计或制造，并符合本部分要求的质量体系。Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.Subpart B质量体系要求/ Quality System RequirementsSec.820.20 管理职责/ Management responsibility（a） 质量方针：负有执行职责的管理者应建立质量方针和目标以及在质量方面的承诺，应保证组织内所有级别都能正确理解并执行质量方针。(a)Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.（b） 组织：建立并保持适宜的组织结构，确保产品的设计和生产符合本部分（Part 820）的要求。(b)Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.（1） 职责和权限。制造商应明确影响质量的管理、操作和评价人员的职责、权限及相互关系，为其提供执行这些工作必需的自主权和权限。(1)Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.（2） 资源。制造商应提供适当的资源，包括由经过培训的人员，执行管理、操作和包括内部质量审核在内的活动，以符合本部分（Part 820）的要求。2)Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.（3） 管理者代表。最高管理者应在管理层中以书面方式指定一名管理者代表，无论其在其它方面的职责如何，应具有以下方面的职责和权限：(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:（i） 确保根据本部分（Part 820）的要求有效地建立、实施和保持质量管理体系；(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and（ii） 向负有执行职责的管理者报告质量体系运行情况，以供评审。(ii) Reporting on the performance of the quality system to management with executive responsibility for review.（c） 管理评审。负有执行职责的管理者，应按程序规定的时间间隔对质量体系进行审核。确保质量体系的持续适宜性和有效性，以满足本标准的要求和组织规定的质量方针和目标。评审的日期和结果应形成文件并记录。(c)Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturers established quality policy and objectives. The dates and results of quality system reviews shall be documented.（d） 质量策划。制造商应建立质量策划，确定设计和制造设备所需的质量准则、资源和活动，形成质量计划。组织应确定如何满足质量要求。(d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.（e） 质量体系程序。制造商应建立质量体系程序和规范，适用时应建立质量体系的文件化的结构描述。(e)Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.Sec.820.22 质量审核Quality audit.制造商应建立并实施质量审核程序和活动，以确保质量体系符合既定的质量体系要求，确定质量体系的有效性。质量审核应由与所审核的活动无直接责任的人员进行。纠正措施，必要时包括对不符合项的重新审核。每次质量审核和重新审核的结果应形成报告，报告要经对审核负有责任的管理者评审。审核和重新审核的日期和结果应予记录。Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.Sec.820.25 人