美國FDA 醫療器械體系法規QSR820中文版Part 820質量體系法規目錄Subpart A- 總則 820.1 范圍 820.3 定義 820.5 質量體系Subpart B 質量體系要求 820.20 管理職責 820.22 質量審核 820.25 人員Subpart C- 設計控制 820.30 設計控制Subpart D- 文件控制 820.40 文件控制Subpart E- 采購控制 820.50 采購控制Subpart F- 標識與可追溯性 820.60 標識 820.65 可追溯性Subpart G - 生產和過程控制 820.70 生產和過程控制 820.72 檢驗、測量和試驗設備 820.75 過程確認Subpart H - 驗收活動: 820.80 進貨、過程和成品器械檢驗 820.86 檢驗狀態Subpart I 不合格品 820.90 不合格品Subpart J - 糾正和預防措施 820.100 糾正和預防措施Subpart K 標識和包裝控制 820.120 設備標簽 820.130 設備包裝Subpart L 搬運/儲存/分銷和安裝820.140 搬運 820.150 貯存 820.160 分銷 820.170 安裝Subpart L 記錄 820.180 記錄的通用要求 820.181 設備主要記錄 820.184 設備歷史記錄 820.186 質量體系記錄 820.198 投訴文件Subpart M 服務 820.200 服務Subpart N 統計技術 820.250 統計技術Subpart A總則Subpart A-General ProvisionsSec.820.1 范圍Sec. 820.1 Scope.（a） 適用性Applicability。（1） 本質量體系法規闡明了當前良好制造法規Current good manufacturing practice（CGMP）的要求。本標準適用于所有預期用于人類的成品器械的設計、制造、包裝、標識、儲存、安裝和服務中所使用的管理方法、設施和控制。本標準的目的是保證成品器械的安全性和有效性，并符合聯邦食品、藥品和化妝品法案Federal Food, Drag and Cosmetic Act （the act）。本法規適用于所有的醫療器械成品制造商。如果制造商僅從事本部分有要求服從的某些過程而未從事其它過程，則只需符合其實施的過程的要求。對于類設備，設計控制僅適用于Sec.820.30（a）（2）中列出的設備。本法規不適用于成品器械的部件或零件制造商，但鼓勵這類制造商把本法規的適當規定作為指南來使用。人血和血液成分制造商不受本部分法規的限制，但應遵循本章606部分法規的要求。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） 本部分的規定適用于本部分定義的預期用于人體的所有成品器械，不論其在美國(包含:美國任何州或領土,哥倫比亞特區,波多黎各聯邦)本土制造還是進口,提供進口的產品。(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） 在本法規中“適用時”（where appropriate）出現過多次。當要求根據“where appropriate”被認為是合格時，其要求應被認為是“適用的”（appropriate），除非組織能提供文件證明其理由。如果不執行預期結果會導致產品不符合其特定的要求，或組織不需要執行任何必要的糾正措施，那么要求就是適用的（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。除非特別規定，則本部分質量體系法規是本章其它部分法規的補充要求。在不能符合所有適用的法規，包括本章此部分和其它部分的情況，特別是對討論中的設備，此法規應取代其它通用要求。(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） 權限。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下建立并發布的。不符合本部分（Part 820）的任何適用的規定，依據法令section 501（h）條款，可判定該產品為偽劣產品。這類產品及對此不符合負責的任何個人，將依法被起訴。(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） 外國制造商。如果把器械進口到美國的制造商拒絕允許或同意FDA對其外國工廠履行為確定器械是否符合本法規（Part 820）所進行的檢查，可按section 801（a）條款對其提出訴訟。即準備出口到美國的設備，其設計、生產、包裝、標簽、貯存或服務中使用的方法和設備控制不符合本法令section 520（f）和本部分（Part 820）的要求，可按本法令section 501（h）條款判定在此條件下制造的產品為偽劣產品。(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） 豁免或特別許可/ Exemptions or variances（1） 任何人希望得到任何醫療器械質量體系要求的豁免或特別許可，應符合法令section 520（f）（2）的要求。根據本章Sec.10.30即FDA行政程序，來提交豁免或特別許可的申請。可以從器械和輻射健康中心和小型制造商援助處獲得指導，地址（HFZ-220），1350 Piccard Dr.，Rockville，MD20850，U.S.A.，電話1-800-638-2041或1-301-443-6597，傳真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） 在有關部門確定此種改變符合美國公眾健康的最佳利益時，FDA可能發起并同意器械質量體系的特別許可。公在美國公眾健康確實需要該設備，且如無此特別許可，則器械就不可能充分有效的生產的情況下，特別許可才有效。(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） 本部分不適用于本章897部分定義的煙草銷售商。Sec.820.3 定義 / 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中的定義在本部分法規中均適用。(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） 投訴Complaint。在設備交付后所有的書面的、電子的或口頭的，對設備的標識、質量、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。所有意圖用來包含成為已完成的、包裝、標識的器械的一部分的原材料、物資、構件、零件、軟件、固件、連接件、標簽或它們的集合。(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） 控制號Control number。任何鑒別性符號，如由字母、數字或它們的組合形成的唯一性組合，由控制號可以確定一批或一個器械的制造、包裝、標識和交付的歷史。(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） 設計歷史文件Design history file（DHF）。成品器械的設計歷史記錄的匯總。(e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device.（f） 設計輸入Design input。器械實體和性能要求，是產品設計的基礎。(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.（g） 設計輸出Design output。是指每個設計階段和最后所有的設計成果的結果。已完成的設計輸出是器械主記錄的基礎。全部最終完成的設計輸出，由器械及其包裝和標識和設備主記錄組成。(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） 設計評審Design review。是指對設計的一個文件化的、全面的、系統的檢查，評價其滿足設計要求，評價其有能力滿足要求，并識別任何問題。(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） 設備歷史記錄Device history record（DHR）。成品器械歷史記錄的匯總。(i)Device history record (DHR ) means a compilation of records containing the production history of a finished device.（j） Device master record（DMR）。成品器械的程序和規范的匯總。(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.（k） 建立Establish。定義文件（書面或電子的）并執行。(k)Establish means define, document (in writing or electronically), and implement.（l） 成品器械Finished device。設備或其附件，無論其是否包裝、標識或滅菌，能夠滿足使用要求或者說能夠實現其功能。(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。一個或多個元件或成品器械，均為同一種規格、型號、尺寸、成分或軟件版本，在相同條件下生產，滿足相同的特性和質量要求。(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） 執行職責的管理者Management with executive responsibility。是組織的高級員工，他們負有建立或更改組織的質量方針和質量體系的職權。(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/組織Manufacturer。是指設計、制造、制作（fabricate）、裝配或加工成品器械的任何人。制造商包括但不僅限于根據合同執行滅菌、安裝、重新標識、重新制造、重新包裝或特定的開發職責的制造商，和執行這些職責的國外組織的國內分銷商。(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過程的任何原料或物質，在制造過程中產生的伴隨的成分或副產品，其在成品器械中/上呈現為殘留物或雜質，它不是制造商的設計或意圖。(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。未滿足規定的要求。(q)Nonconformity means the nonfulfillment of a specified requirement.（r） 產品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） 質量Quality。一組固有特性滿足要求的程序，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） 質量審核Quality Audit。按規定的時間間隙和頻率，對制造商的質量體系進行系統、客觀的檢查，以確定質量體系活動及其結果符合質量體系程序，這些程序得到有效執行，程序適應質量目標的需求。(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） 質量方針Quality policy。由制造商的最高管理者發布的組織總的質量宗旨和方向。(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.（v） 質量體系Quality system。質量管理的組織結構、職責、程序、過程和資源。(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.（w） Remanufacturer。指對成品器械進行處理、修整、修復、重新包裝、恢復或其它活動的人，使成品器械的性能、安全規范或預期用途產生重大更改。(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。為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） 規范Specification。產品、過程、服務或其它活動應符合的要求。(y)Specification means any requirement with which a product, process, service, or other activity must conform.（z） 確認Validation。通過檢查和提供客觀證據證明滿足預期用途的要求。(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） 過程確認Process validation。根據客觀證據確定過程可持續產生滿足預先確定規范的結果或產品。(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.（2） 設計確認Design validation。根據客觀證據確定設備規范符合使用者的需求和預期用途。(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).（aa） 驗證Verification。通過檢查和提供客觀證據證明滿足規定的要求。(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec.820.5 質量體系/ Quality system.制造商應建立并實施適應特定的醫療器械設計或制造，并符合本部分要求的質量體系。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質量體系要求/ Quality System RequirementsSec.820.20 管理職責/ Management responsibility（a） 質量方針：負有執行職責的管理者應建立質量方針和目標以及在質量方面的承諾，應保證組織內所有級別都能正確理解并執行質量方針。(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） 組織：建立并保持適宜的組織結構，確保產品的設計和生產符合本部分（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） 職責和權限。制造商應明確影響質量的管理、操作和評價人員的職責、權限及相互關系，為其提供執行這些工作必需的自主權和權限。(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） 資源。制造商應提供適當的資源，包括由經過培訓的人員，執行管理、操作和包括內部質量審核在內的活動，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。最高管理者應在管理層中以書面方式指定一名管理者代表，無論其在其它方面的職責如何，應具有以下方面的職責和權限：(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） 確保根據本部分（Part 820）的要求有效地建立、實施和保持質量管理體系；(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and（ii） 向負有執行職責的管理者報告質量體系運行情況，以供評審。(ii) Reporting on the performance of the quality system to management with executive responsibility for review.（c） 管理評審。負有執行職責的管理者，應按程序規定的時間間隔對質量體系進行審核。確保質量體系的持續適宜性和有效性，以滿足本標準的要求和組織規定的質量方針和目標。評審的日期和結果應形成文件