QMSR法规修订问答（翻译）

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PART 820—QUALITY MANAGEMENT SYSTEM REGULATION

第820 部分——质量管理体系法规QMSR

Subpart A--General Provisions

A分部——一般规定

Sec.

820.1 Scope.范围

820.3 Definitions.定义

820.5 [Reserved]保留

820.7 Incorporation by reference.通过引用并入

820.10 Requirements for a quality management system.质量管理体系的要求

Subpart B--Supplemental Provisions

820.20--820.30 [Reserved]保留

820.35 Control of records.记录控制

820.40 [Reserved]保留

820.45 Device labeling and packaging controls.设备标签和包装控制

Subparts C--O [Reserved]保留

Authority参考: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374,

381, 383; 42 U.S.C. 216, 262, 263a, 264.

Subpart A--General Provisions

A分部——一般规定

§ 820.1 Scope.范围

(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this

quality management system regulation (QMSR). 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 assure that finished devices will be safe and effective and otherwise in compliance with

the Federal Food, Drug, and Cosmetic Act and that the use of other terminology, such as “safety and

performance,” in this part does not change this statutory standard or the requirements of this part. Any

manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or

servicing of a finished device must establish and maintain a quality management system that is

appropriate for its specific device(s). Manufacturers subject to this part include, but are not limited to,

manufacturers that perform the functions of contract sterilization, installation, relabeling,

remanufacturing, repacking, or specification development, as well as initial distributors of foreign

entities that perform these functions. 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.

(a) 适用性。本质量管理体系法规 (QMSR) 中规定了当前的良好生产规范 (CGMP) 要求。本部

分的要求适用于所有供人类使用的成品设备的设计、制造、包装、标签、存储、安装和维修

所使用的方法以及所使用的设施和控制措施。本部分中的要求旨在确保成品设备安全有效，

并符合联邦食品、药品和化妆品法。任何从事成品器械设计、制造、包装、标签、存储、安

装或维修的制造商都必须建立和维护适合其特定器械的质量管理体系。受本部分约束的制造

商包括但不限于执行合同灭菌、安装、重新贴标签、再制造、再包装、或规格开发，以及执

行这些功能的外国实体的初始分销商。如果制造商仅从事本部分要求的某些操作，而不从事

其他操作，则该制造商只需遵守适用于其所从事操作的那些要求。

(1) Finished devices. The provisions of this part shall apply to any finished device, as defined in this

part, intended for human use, that is manufactured in any State or Territory of the United States, the

District of Columbia, or the Commonwealth of Puerto Rico, or that is imported or offered for import

into the United States.

(1) 成品器械。本部分的规定应适用于本部分定义的任何供人类使用的成品器械，该器械在美国

任何州或领地、哥伦比亚特区或波多黎各联邦。

(2) Components or parts. The provisions of this part do not apply to manufacturers of components or

parts of finished devices, but such manufacturers are encouraged to consider provisions of this

regulation as appropriate.

(2) 组件或零件。本部分的规定不适用于成品器械零部件的制造商，但鼓励此类制造商酌情考虑

本法规的规定。

(3) Blood and blood components. The provisions of this part do not apply to manufacturers of blood

and blood components used for transfusion or for further manufacturing. Such manufacturers are

subject to subchapter F of this chapter.

(3) 血液和血液成分。本部分的规定不适用于用于输血或进一步制造的血液和血液成分的制造商

。此类制造商受本章 F小节的约束。

(4) HCT/Ps. The provisions of this part apply to manufacturers of human cells, tissues, and cellular

and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are devices (subject

to premarket review or notification, or exempt from notification, under an application submitted under

the device provisions of the Federal Food, Drug, and Cosmetic Act or under a biological product

license application under section 351 of the Public Health Service

Act). HCT/Ps regulated as devices are also subject to the donor-eligibility requirements set forth in

part 1271, subpart C of this chapter and applicable current good tissue practice requirements 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 regulation.

(4) HCT/Ps。本部分的规定适用于人体细胞、组织以及基于细胞和组织的产品 (HCT/Ps) 的制造

商，如本章 § 1271.3(d) 中所定义，这些设备是设备（须经上市前审查或通知，根据《联邦食品

、药品和化妆品法》的器械条款提交的申请或根据《公共卫生服务法》第 351 条提交的生物产

品许可申请，或免于通知）。作为器械监管的 HCT/Ps 还需遵守本章第 1271 部分 C小节中规定

的供体资格要求以及本章第 1271 部分 D小节中适用的现行良好组织实践要求。如果第 1271 部

分的适用法规与本章其他部分的适用法规发生冲突，则具体适用于相关设备的法规应取代更一

般的法规。

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标签： #QMSR

摘要：

PART820—QUALITYMANAGEMENTSYSTEMREGULATION第820部分——质量管理体系法规QMSRSubpartA--GeneralProvisionsA分部——一般规定Sec.820.1Scope.范围820.3Definitions.定义820.5[Reserved]保留820.7Incorporationbyreference.通过引用并入820.10Requirementsforaqualitymanagementsystem.质量管理体系的要求SubpartB--SupplementalProvisions820.20--820.30[Reserved]保留8...

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