New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译

医疗器械与体外诊断用品的良好生产技术规范

TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES AND

PRODUCTS FOR IN VITRO DIAGNOSTIC USE

注：参考葡萄牙语-英语翻译版本

美国食品和药物管理局质量体系要求第21章第820节的基本术语。

Note: The translation from Portuguese to English used as reference

the basic terminology of the FDA QSR 21 Part 820.

巴西国家卫生监督局——联合董事会决议第16号RDC2013年3月28日

ANVISA - COLLEGIATE BOARD RESOLUTION

RDC No.16 28 MAR 2013

批准医疗用品与体外诊断用品的良好生产技术规范及其他措施。

Approves the Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use and other measures.

巴西国家卫生监督局在2013年3月7日召开的会议上，根据第1999年4月16日3029号法令批准的规范的第11条第4款规定，以及根据巴西国家卫生监督局的第354号法令附录一批准的附则的第54条第1款与第3款规定获得授权行使权力，公布于2006年8月21日的公报上。参考1976年9月23日生效的6360号法案及其规定，以及1977年1月5日的79094号法令；

The Board of the National Health Surveillance Agency, in exercise of the powers conferred upon him by section IV of article. 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of section II and in § 1 and § 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA,

of August 11, 2006, republished in the Official Gazette of August 21,

2006, at a meeting held March 7, 2013, considering the Law. 6360 of September 23, 1976 and its regulations, Decree No. 79094 of January 5, 1977;

参考了内在化决议南美共同市场/GMC/RES的需要。参考了内在化20/11号南美共同市场/GMC/RES.决议，批准了“南北共同市场医疗用品与体外诊断用品的良好生产技术规范”（废除了第04/95、38/96、65/96与131/96号的GMC决议）；

considering the need to internalize the Resolution MERCOSUR / GMC / RES. No. 20/11, which approved the "MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use (repeal of

GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ";

考虑到医疗用品与体外诊断用品的生产规范规则应保证在巴西出售用品的质量、安全与功效。

considering that the rules of Good Manufacturing Practices relating to

medical products and products for in vitro diagnostic use should seek

to guarantee the quality, safety and efficacy of the products marketed

in Brazil;

因此，医疗用品与体外诊断用品监管体制的优化推动工作至关重要；

Whereas it is essential to promote the improvement of national systems

aimed at the regulation and control of medical products and products for in vitro diagnostic use;

基于以下董事会决议，本人作为总裁，宣布发表：

adopts the following resolution of the Board and I, the Chairman, determine its publication:

第1条规定，批准“医疗用品与体外诊断用品的良好生产技术规范”。该规范作为附录，是本决议的组成部分。

Art 1st - Approve the "Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use", which is included as Annex and part of this resolution.

单一段落。本规范含国家法律体制规范GMC MERCOSUR第20号2011年“南方共同市场医疗用品与体外医疗用品的良好生产技术规范（废除第04/95、38/96、65/96与131/96号GMC决议）”。

Single paragraph. This regulation incorporates the national legal system Resolution GMC MERCOSUR No. 20/2011 "MERCOSUR Technical Regulation

of Good Manufacturing Practice for Medical Products and Products for Diagnostic Use In Vitro (repeal of GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ".

第2条：替代1998年8月27日的第686号法令，2000年6月27日发布的第59号RDC决议，以及2004年7月2日发布的第167号RDC决议。

Article 2: - Repealing Ordinance No. 686, of August 27, 1998, the RDC

Resolution No. 59, dated June 27, 2000, and Resolution RDC No. 167 of

July 2, 2004.

第3条——适用时，医疗用品与体外诊断用品的经销商与存放/托管人应符合决议要求。

Article 3 - Distributors and storage/hosts of medical products and diagnostic products for use in vitro should meet the requirements of this

Resolution, as applicable.

第4条——并入此法律文件后180日之内可采取必要的措施落实本技术规范。

Article 4 - It is granted within 180 days from the date of incorporation of the legislative instrument, to adopt the measures necessary for

the implementation of the Technical Regulations.

第5条——该决议于公布之日生效。

Article 5 - This Resolution shall enter into force on the date of its

publication.

DIRCEU BRÁS APARECIDO BARBANO

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附件

ANNEX

医疗用品与体外诊断用品的良好生产技术规范

TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL PRODUCTS AND

PRODUCTS FOR IN VITRO DIAGNOSTIC USE

目录

CONTENT

第1章——总则

CHAPTER 1 - GENERAL PROVISIONS

第2章——一般质量体系要求 Part B

CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM

2.1. 总则

2.1. General provisions

2.2.管理职责

2.2. Managerial responsibility

2.3.雇员

2.3. Staff

2.4.风险管理

2.4. Risk Management

2.5.采购控制

2.5. Purchasing Control

第3章——文件和记录 Part D

CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY

3.1. 一般要求

3.1. General requirements

3.2.器械历史记录

3.2. Device History Record (DHR)

3.3.检测和试验记录

3.3. Records of inspections and tests

第4章——设计开发文档 Part C

CHAPTER 4 - DESIGN CONTROL AND DEVICE MASTER RECORD (DMR)

4.1.设计控制

4.1. Design Control

4.2.器械主文档

4.2. Device Master Record (DMR)

第5章——产品过程控制 partG

CHAPTER 5 - PROCESS AND PRODUCTION CONTROLS

5.1. 总则

5.1. General Instructions

5.2. 包装，标签和使用说明书 partL

5.2. Controls packaging, labeling and instructions for use

5.3. 检验和测试 Part

H

5.3. Inspection and testing

5.4.检测设备的要求

5.4. Inspection and test of measuring equipments.

5.5. 确认

5.5. Validation

5.6.变更控制

5.6. Change Control

第6章——搬运、储存、分销的可追溯性 Part K搬运、存储、交付和安装

CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACEABILITY

6.1.处置

6.1. Handling

6.2. 存贮

6.2. Storage

6.3.分销

6.3. Distribution

6.4.可追溯性

6.4. Identification and traceability

6.5.产品的符合性

6.5. Non-compliant components and products

第7章—— 纠正预防措施 Part J 纠正措施

SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS

7.1.纠正和预防措施

7.1. Corrective and Preventive Actions

7.2.投诉的管理

7.2. Management of complaints

7.3.质量审核

7.3. Quality audit

第8章——安装和服务 Part K 搬运、存储、交付和安装

CHAPTER 8 - INSTALLATION AND SERVICING

8.1.安装

8.1. Installation

8.2.技术援助和服务

8.2. Technical Assistance/Servicing

第9章——统计技术 Part O

CHAPTER 9 - STATISTICAL TECHNIQUES

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第1章——总则

CHAPTER 1 - GENERAL PROVISIONS

1.1——适用性

1.1 - Applicability

1.1.1.本技术规范说明了对医疗用品与体外诊断用品的制造要求。这些要求说明了医疗用品与体外诊断用品的设计、采购、制造、包装、贴标、存放、配送、安装及维修方法与管理的良好生产规范(GMP)。本技术规范的要求旨在保证医疗用品与体外诊断用品的安全性与有效性。

1.1.1. This Technical Regulation establishes requirements for the manufacture of medical products and products for in vitro diagnostic use.

These requirements describe the Good Manufacturing Practices (GMP) for

methods and controls used in the design, purchase, manufacturing, packaging, labeling, storage, distribution, installation and servicing of

medical products and products for in vitro diagnostic use. The requirements of this Technical Regulation are intended to ensure that medical

products and products for in vitro diagnostic use are safe and effective.

1.1.1.2.本技术规范的要求适用于在巴西销售的体外诊断用品的制造商与进口商。

1.1.1.2. The requirements of this Technical Regulation are applicable

to manufacturers and importers of medical devices and diagnostic products for use in vitro that are commercialized in Brazil.

1.1.3.制造商认为本决议的任何要求不适用于自身情况的，应提交相应的书面理由说明。

1.1.3. Where the manufacturer understand that any of the requirements

of this resolution does not apply to their cases, shall document justification for such understanding.

1.1.1.4.适用时，医疗用品与体外诊断用品的进口商应符合决议要求。

1.1.1.4. Importers of medical and diagnostic products for use in vitro

should meet the requirements of this Resolution, as applicable.

1.2.定义

1.2. Definitions

在本技术规范采用下列定义：

For the purposes of this Technical Regulation the following definitions apply:

1.2.1.技术协助/维修：为使成品达到规范要求而开展的维护或维修。

1.2.1. Technical Assistance/Servicing: Maintenance or repair of a finished product to return it to your specifications.

1.2.2.质量审查：一项定期以适当频率开展的，独立于制造商所有质量体系的系统化审查，用于确认质量体系活动或其结果是否符合贵方质量体系程序的要求，确保有效落实程序，实现质量体系目标。质量审查与本技术规范要求的其他质量体系活动不同。

1.2.2. Audit quality: means an established examination, systematic and

independent of all quality system from a manufacturer, performed at regular intervals and with sufficient frequency to ensure that either the activities of the quality system or their results satisfy the procedures specified in your quality system, and that these procedures are implemented efficiently and that are appropriate to achieve the objectives of the quality system. The quality audit is different from other activities of the quality system required by this Technical Regulation.

1.2.3.组成部分：医疗用品与体外诊断用品的生产过程中使用的，作为成品组成部分的原材料、物质、组件、零件、软件、硬件、包装、标签或使用说明。

1.2.3. Component: raw material, substance, piece, part, software, hardware, packaging, labeling or instructions for use which are used durin

g the manufacture of a medical product and product for diagnostic use

in vitro, to be included as part of the finished product.

1.2.4.项目/设计输入：作为贵方项目依据的物理特性、使用说明、性能、兼容性、安全性、功效、人体工程学理论、可用性、先前项目信息与风险管理结果，以及医疗设备或体外诊断用品的其他要求。

1.2.4. Project /Design Input : description of physical attributes, indication for use, performance, compatibility, security, efficiency, ergonomics, usability, information from previous projects and results of

risk management, among other requirements of a medical device or diagnostic product use in vitro that are used as the basis for your project.

1.2.5.项目/设计输出：项目各阶段成果及其最终结果。完成项目的输出数据是产品主记录(PMR)/器械主记录(DMR)的依据。

1.2.5. Project/Design Output : outcome of the work in each phase of the project and its final result. The output data of finished project is

the basis for the product master record (PMR)/Device Master Record (DMR) .

1.2.6.损害：对人员健康的物理伤害，或者财产或环境的损坏。

1.2.6. Damage: physical injury or harm to the health of the person, or

damage to property or the environment.

1.2.7.规范：各种产品、成分、生产活动、技术协助服务、质量体系或其他活动必须符合的要求。

1.2.7. Specifications: requirements that products, components, production activities, technical assistance services, quality system or any other activity must conform.

1.2.8.确立：定义、记录（通过书面或电子手段）与实施。

1.2.8. Establish: define, document (through written or electronic) and

implement.

1.2.9.厂商：负责设计、制造、组装或处理成品的任何人，包括消毒、贴标与包装人。

1.2.9. Manufacturer: means any person who designs, manufactures, assembles or processes a finished product, including those who perform contract sterilization, labeling, packaging.

1.2.10.行政管理层：负责提供资源与授权变更政策与质量体系的高层管理人员。

1.2.10. Executive management: top management responsible for providing

resources and authority to establish or change policy and quality system of the company.

1.2.11.风险管理：各种分析、评估、控制与管理特定产品或流程相关风险的政策、程序与管理规范的系统化应用。

1.2.11. Risk Management: the systematic application of policies, procedures and management practices to the tasks of analyzing, evaluating,

controlling and monitoring risks associated with a particular product

or process.

1.2.12.批次：来自同一生产或消毒周期的，关键特性相同的产品之数量。

1.2.12. Lot or batch: quantity of a product produced in a cycle of manufacturing or sterilization, whose essential characteristic is homogeneity.

1.2.13.原材料：用于生产或促进生产的材料或物质，包括清洁剂、脱模剂、润滑剂、消毒剂或生产流程中的其他副产品。

原材料：

1.2.13. Manufacturing Material: material or substance used in the manufacturing process or to facilitate this process, including cleaning agents, mold release agents, lubricants, sterilizing, or other byproducts of the manufacturing process.

1.2.14.不合格: 未满足事先规定的各项要求。

1.2.14. Nonconformity: non-fulfillment of requirements specified in advance.

1.2.15.序号或批号：可追溯采购、制造、包装、贴标及成品分销信息的唯一字母/数字/字母+数字组合。

1.2.15. Serial Number or Lot: distinctive combination of letters or numbers, or both, which can be given a complete history of purchasing, manufacturing, packaging, labeling and distribution of finished products.

1.2.16.危害：潜在风险。

1.2.16. Hazard: Potential source of harm.

1.2.17.质量政策：行政管理人员明示的组织关于质量的一切目的与指示。

1.2.17. Quality Policy: all the intentions and directives of an organization with regard to quality, expressed by executive management.

1.2.18. 特殊工艺：无法通过后续检查与测试充分核实结果的任何流程。

1.2.18. Special Process: any process whose results cannot be fully verified by subsequent inspection and testing.

1.2.19.生产：制造产品所涉及的所有运作，从接收成分、处理、包装，到实现成品。

1.2.19. Production: all operations involved in the manufacture of a product, from receipt of components, through processing and packaging, to obtain the finished product.

1.2.20.成品：适合使用的已包装或已贴标的产品或配件。

1.2.20. Finished product: any product or accessory suitable for use, packed, labeled.

1.2.21.质量：使某一医疗用品或体外诊断用品符合使用要求（包括安全与性能）的全体功能与特点。

1.2.21. Quality: the totality of features and characteristics that enable a medical product or product for diagnostic use in vitro meet the

requirements of fitness for use, including safety and performance.

1.2.22.投诉：否定产品特性、质量、耐用性、安全性、效果或性能的书面、口头或电子沟通。

1.2.22. Complaint: written communication, oral or electronic on the rejection of identity, quality, durability, reliability, safety, effectiveness, or performance of a product.

1.2.23.记录：符合标准与质量系统程序要求的，展示数据、事实、特定情况及成果的纸质或电子文件。

1.2.23. Records: physical or electronic document, which shows data, facts, specific events and achievements in relation to compliance with standards and procedures of the quality system.

1.2.24.产品历史记录/设备历史记录(DHR)：成品制造完整历史信息的记录。

1.2.24. Historical record of the product/Device History Record (DHR):

compilation of records containing the complete history of producing a

finished product.

1.2.25.项目历史记录/设计历史文件(DHF)：从项目到成品的完整历史信息的文件。

1.2.25. Historical record of the project/Design History File (DHF): compilation of documents containing the complete history of the project

to a finished product.

1.2.26.产品主记录(PMR)/设备主记录(DMR)：含实现成品、安装、维修与服务的规范、指示与程序的文件。

1.2.26. Product Master Record (PMR)/Device Master Record (DMR): compilation of documents containing specifications, instructions and procedures to obtain a finished product as well as installation, service and

maintenance.

1.2.27.返工：用于整改某一不合格成分、中间产品或成品，使其符合产品主记录/设备主记录规范的部分或全部制造活动。

1.2.27. Rework: part or all of the manufacturing operation designed to

correct non-conformity of a component, the intermediate product or a finished product, so that it meets the specifications set out in PMR/DMR.

1.2.28.项目/设计审查：项目开发过程中实施的配有文件、系统化且完整实施的检查，用于评估规划与目标的适当性。

1.2.28. Project/Design review: examination documented, systematic and

complete performed during the development of the project to assess the

adequacy of the same planning and objectives.

1.2.29.风险：发生概率与破坏程度的结合。

1.2.29. Risk: Combination of the probability of occurrence and severity of damage.

1.2.30.质量体系：质量管理的组织化结构、职责、程序、规范、流程及资源。

1.2.30. Quality system: organizational structure, responsibilities, procedures, specifications, processes and resources for quality management.

1.2.31.确认：通过检查与客观证明，验证针对特定目的提出的要求持续获得预期结果。就项目而言，确认指确立并记录客观证据，证明产品规范符合用户需求及其目标用途。就流程而言，确认指确立并记录客观证据，证明流程将持续产生符合既定规范的结果。

1.2.31. Validation: Confirmation by examination and objective evidence

that the requirements defined for a particular purpose lead, consistently, the expected result. With respect to a project, means to establish and document objective evidence that the product specifications meet

user needs and its intended use. With respect to a process means to establish and document objective evidence that the process will consistently produce a result that meets the predetermined specifications.

1.2.32.验证：检查并提供客观证据，证明满足特定要求。验证流程包括检查某一活动的记录，确定符合确立的规范。

1.2.32. Verification: confirmation by examination and presentation of

objective evidence that specified requirements have been met. The verification process includes examining the results of an activity to determine compliance with established specifications.

1.2.33.生命周期：厂商预计产品可正常发挥设计功能的时长。

1.2.33. Life time: time estimated by the manufacturer that a product complies correctly functions for which it was designed.

第2章——质量体系一般要求

CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM

2.1.总则

2.1. General Provisions

2.1.1.每个厂商应建立并维护一个质量体系，确保满足本技术规范的要求，并保证生产的产品安全、有效，适合预期用途。对于质量体系，每个厂商需要开展下列活动：

2.1.1. Each manufacturer shall establish and maintain a quality system

to ensure that the requirements of this Technical Regulation are met and that the products manufactured are safe, effective and appropriate

for the intended use. As part of its activities on the quality system,

each manufacturer must:

2.1.1.1.根据本技术规范的要求，建立并维护使用说明和有效质量体系程序，并

2.1.1.1. Establish and maintain instructions and effective quality system procedures in accordance with the requirements of this Technical Regulation, and

2.1.1.2.建立符合当前健康法/卫生法/监督法的规定的程序。

2.1.1.2. Establish procedures for compliance with the legal provisions

contained in current health/sanitary surveillance laws.

2.2.管理责任

2.2. Managerial responsibility

2.2.1.质量政策。每个厂商的行政管理层的任务包括建立与已有政策一致的可量化政策和目标，以实现质量承诺。行政管理层负责维护组织内各个层级的政策。行政管理层负责确保上述政策包含于质量手册之中，并且所有影响产品质量的员工都理解掌握这些政策。

2.2.1. Quality Policy. The executive management of each manufacturer shall establish its policy and objectives of commitment to quality, which should be measurable and consistent with the established policy. Executive management should maintain the policy at all levels of the organization. Executive management should ensure that this policy is desc

ribed in a quality manual and understood by all employees who may affect or influence the quality of a product.

2.2.2.组织每个厂商应根据组织系统图，建立并维护适当的组织结构，任命有效率的员工，确保生产的产品符合本技术规范的要求。

2.2.2. Organization. Each manufacturer shall establish and maintain an

appropriate organizational structure, represented by the organization

chart, with sufficient staff to ensure that products are manufactured

in accordance with the requirements of this Technical Regulation.

2.2.3.职责及权限每个厂商应根据本规范中每一章节的要求，落实管理、执行并验证质量相关工作的所有员工的职责、权限和相互关系，并确保员工拥有必要的独立性去完成各自职责。

2.2.3. Responsibility and Authority. Each manufacturer shall establish,

for each chapter of this Technical Regulation, responsibility, authority and interrelation of all personnel who manage, perform and verify work relating to quality, with the necessary independence to perform its responsibilities.

2.2.4.待验证的资源与人员每个厂商应确定验证职能，提供充足的资源，任命经培训的人员开展验证活动。

2.2.4. Resources and personnel for verification. Each manufacturer shall establish verification functions, and must provide adequate resources and assignment of trained personnel to carry out verification activities.

2.2.5.管理层代表每个厂商的行政管理层应指派一个人作为代表，并将任命决定记录存档。在不考虑其他职能的情况下，受任命的代表有以下权限和职责：

2.2.5. Management representative. The executive management of each manufacturer shall designate an individual of this, and document this designation, which, irrespective of other functions, will have authority

and responsibility for:

2.2.5.1.确保根据本技术规范的要求建立并维护质量体系要求；

2.2.5.1. Ensure that the requirements of the quality system are established and maintained in accordance with this Technical Regulation;

2.2.5.2.将质量体系的执行情况报告给行政管理层进行审查，并提供改善质量体系的相关信息。

2.2.5.2. Report the performance of the quality system to executive management for review and providing information on the improvement of the

quality system.

2.2.6.管理审查每个厂商的行政管理层应根据规定的时间间隔评估质量体系的充分性和有效性，并保证充分的评估次数，确保质量体系满足本技术规范的要求且符合建立的质量政策的目标。管理审查应根据已有的审查程序开展，对质量体系每次审查的结果都应进行记录。

2.2.6. Management review. The executive management of each manufacturer should evaluate the adequacy and effectiveness of the quality system

at defined intervals and with sufficient frequency to ensure that the

quality system satisfies the requirements of this Technical Regulation,

and complies with the objectives of the quality policy established. The management review shall be conducted in accordance with established

review procedures and the results of each review of the quality system

shall be documented.

且管理审查应考虑与审计结果、上市后信息、过程性能和产品合格性、预防措施和保护措施状态、影响质量体系或产品合规性的变更、法规要求等有关的事宜。

Should be considered for review matters relating to audit results, post-marketing information, process performance and product conformity, status of preventive and corrective actions, changes that could affect

the quality system or product compliance, regulatory requirements, among other .

2.3.人事部门

2.3. Personnel

2.3.1.一般说明每个厂商应配备足够的人员，他们的教育、经验、培训和实践经验要与职位责任相符，确保本技术规范中的所有活动都能够正确执行。说明权限、责任和公司各种任务的要求。

2.3.1. General Instructions. Each manufacturer shall have sufficient personnel with education, experience, training and practice consistent

with the duties of the position, to ensure that all activities under this Technical Regulation are correctly performed. Should be kept descriptions defining authority, responsibility and requirements for the various tasks of the company.

2.3.2.培训每个厂商应确保所有人员经过充分培训，能够胜任指定的任务。培训需要根据有资格人士确立的程序来开展，确保员工了解他们的常规职责以及本技术规范中适用于他们岗位的要求。

2.3.2. Training. Each manufacturer shall ensure that all personnel are

adequately trained to perform the tasks assigned to it. Training shall

be conducted in accordance with procedures established by qualified persons to ensure that employees have a proper understanding of their regular duties and requirements of this Technical Regulation applicable

to their duties.

培训过程中需要提醒所有员工由于未能正确行使职能可能造成的产品缺陷。

As part of their training, all employees should be warned of defects in products may occur as a result of improper performance of their specific functions.

员工的培训需要进行记录。

The employee training should be documented.

2.3.3.顾问每个厂商应确保每位对员工进行产品设计、采购、制造、包装、贴标签、储存、安装或维修方法和控制进行指导的顾问必须具备足够的资历（教育、培训和经验），才能对职责以内的事项提供建议。

2.3.3. Consultants. Each manufacturer shall ensure that any consultant

to guide employees on methods and controls used for the design, purchase, manufacturing, packaging, labeling, storage, installation or servicing of products has sufficient qualifications (education, training and experience) to advise on matters for which he was hired.

顾问的招聘要根据本技术规范中的采购控制要求来执行。 新增

Hiring consultants should be conducted in accordance with the requirements of Purchasing Control under this Technical Regulation.

2.4.风险管理 新增

2.4. Risk Management

2.4.1.每个厂商应建立并维护一个风险管理的持续流程，涉及产品从概念到停用的整个生命周期，以此确定与医疗设备或体外诊断设备产品相关的危害，评估并监控相关风险，同时衡量已有控制过程的有效性。这个流程应包含风险分析、评估、控制和监控等方面。

2.4.1. Each manufacturer shall establish and maintain an continuous process of risk management which involves the entire product life cycle,

from conception to its discontinuation, to identify the hazards associated with a medical device or product for in vitro diagnostic use, assess and evaluate the risks involved, monitor them and evaluate the effectiveness of established controls. This program should include the following elements: analysis, evaluation, control and monitoring of risk.

2.4.2.公司行政管理层应指定专业负责人，制定确定风险的可接受性准则的政策，并确定对风险管理行动进行审查的周期，确保风险管理的充分性和有效性。

2.4.2. The executive management of the company shall designate the responsible professionals, establish policy for determining the criteria

for acceptability of risk, and determine a periodic review of the risk

management activities to ensure the adequacy and effectiveness of the

same.

2.5.采购控制

2.5. Purchasing Control

2.5.1.每个厂商应建立并维护相关程序，确保组成部分、生产材料和经他人制造、处理、包装、贴标签或储存的成品与相关规范相符。每个厂商还应确保第三方提供的服务与相关规范相符。

2.5.1. Each manufacturer shall establish and maintain procedures to ensure that components, manufacturing materials and finished products manufactured, processed, packaged or labeled by others or stored by them

under the contract, are under conformity with the specifications. Each

manufacturer shall also ensure that the services performed by third parties are under conformity with the specifications laid down by it.

2.5.2.供应商产品和服务的评估每个厂商应根据质量对于成品的影响，建立并维护供应商评估标准，并指定供应商应满足的相关要求，包括质量要求。

2.5.2. Evaluation of suppliers of products and services. Each manufacturer shall establish and maintain, according to the impact on the quality of the final product, criteria for evaluating suppliers,; specifying the requirements, including quality requirements, that they should

meet.

2.5.3.每个厂商应根据供应商的能力以及能够满足已有的要求评估并选择潜在供应商，并记录经过审批的供应商。记录评估过程以及结果。

2.5.3. Each manufacturer shall evaluate and select potential suppliers

according to their ability to meet the requirements previously established, keeping record of approved suppliers. Records must be kept of the assessment records, as well as their results.

2.5.4.采购记录每个厂商应维护采购订单记录，这些记录应清楚说明或参照相关规范，包括组成部分质量要求、制造材料、要求或合同规定的成品或服务。申请审批，包括日期和/或负责人签名电子版必须记录在案。

2.5.4. Purchase record. Each manufacturer shall maintain records of purchase orders that clearly describe or refer to the specifications, including quality requirements for components, manufacturing materials,

finished products or services requested or contracted. The approval of

applications, including the date and or electronic signature of the person responsible, must be documented.

2.5.5.必须为供应商承诺通知厂商产品或服务变更的有文件证明的协议，使得厂商能够确定上述变更是否会对成品的质量造成影响。

2.5.5. Must be documented agreement that suppliers undertake to notify

the manufacturer of any change in the product or service, so that the

manufacturer can determine if the change affects the quality of the finished product.

2.5.6.每个厂商应在采购文件发布之前进行审查和批准。

2.5.6. Each manufacturer shall review and approve purchasing documents

before their release.

第3章——质量相关的文件和记录

CHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY

3.1.一般要求

3.1. General requirements.

3.1.1.每个厂商应建立并维护文件控制程序，确保本技术规范中提及的所有文件均保持正确，并适用于预期用途，同时保证可能对产品质量造成影响的所有员工理解并掌握相关文件。

3.1.1. Each manufacturer shall establish and maintain document control

procedures to ensure that all documents referenced in this Technical Regulation are correct and suitable for the intended use, and are understood by all employees who may affect or influence the quality of a product.

3.1.2.文件审批和发放每个厂商应指定人员审查和批准本技术规范中规定的所有文件内容是否充分，然后才能发放。批准的过程，包括日期和审批人签名的电子版必须附有文件证明。

3.1.2. Approval and issuance of documents. Each manufacturer shall designate persons to review and approve all documents set forth in this Technical Regulation for adequacy prior to issue. The approval, including the date and or electronic signature of the person responsible for

approving the document, shall be documented.

3.1.3.文件分发厂商应确保所有的文件应及时更新，并且在使用场合能够获得，同时应该保证回收所有不必要和老旧的文件，避免非预期使用。

3.1.3. Distribution of documents. The manufacturer shall ensure that all documents are updated and available at the sites of application and

that all unnecessary or obsolete documents are removed from use, or protected from unintended use.

3.1.4.文件变更质量体系相关规范、方法或程序的变更必须由与原来审查人和批准人职位或职责等级相当的人员进行评估、记录、审查和批准。

3.1.4. Change documents. Changes in specifications, methods or procedures relating to the quality system must be evaluated, documented, reviewed and approved by people whose role and level of responsibility are

equivalent to those that performed the original review and approval.

3.1.5.记录文件变更每个厂商应维护文件变更记录，包括变更说明、受影响和变更文件鉴定、责任人鉴定、批准日期和变更生效日期。

3.1.5. Records document changes. Each manufacturer shall maintain records of changes to documents shall contain a description of the change,

identification of affected and altered documents, identification of the responsible person, date of approval and date on which the changes will take effect.

保存文件当前清单，确定文件当前状态并确保只使用经批准的当前文件。

Should be kept current list of documents to identify the current status of the same and ensure that they use only current and approved documents.

3.1.6.文件档案和记录所有文件和质量记录应清晰可辨，并储存起来将损坏降低至最小，防止文件丢失，并提供快速恢复。所有以电子方式保存的文件和记录应进行备份：

3.1.6. Document Archive and Records. All documents and quality records

shall be legible and be stored to minimize damage, prevent loss and provide fast recovery. All documents and records digitally stored should

be backed up:

3.1.6.1.保密性厂商认定的保密文件和记录需要进行标记，以提醒有关卫生当局。新增

3.1.6.1. Confidentiality. The documents and records deemed confidential by the manufacturer may be marked to alert the competent health authority;

3.1.6.2 文件和记录的保留周期：文件记录的保存期限因不低于产品的使用寿命期限，但是不得少于文件分发日期后的两年。 不同

3.1.6.2 Period of retention of documents and records: all records and

documents necessary relating to a product should be kept for a period

of time equivalent to the useful life time of the product, but in no case for less than two years from the date the distribution thereof.

3.2.产品/设备历史记录(DHR)

3.2. Historical record of the product/ Device History Record (DHR)

3.2.1.每个厂商应维护产品的历史记录。每个厂商应建立并维护相关程序，确保产品的历史记录分批或按照不同系列保存，证明产品是根据本技术规范要求和产品主记录进行生产。产品的历史记录应包含或参照以下信息：

3.2.1. Each manufacturer shall maintain historical records of products.

Each manufacturer shall establish and maintain procedures to ensure that the historical records of products are kept for each batch or series to demonstrate that the products were manufactured according to the

master record of the product and the requirements of this Technical Regulation. The historical record of the product should include or refer

to the following information:

3.2.1.1.生产日期；

3.2.1.1. Date of manufacture ;

3.2.1.2.产品部件；

3.2.1.2. Components used;

3.2.1.3.生产数量；

3.2.1.3. Quantity manufactured;

3.2.1.4.检验和测试结果；

3.2.1.4. Results of inspections and tests;

3.2.1.5.特殊过程的参数；

3.2.1.5. Parameters of special processes;

3.2.1.6.放行数量；

3.2.1.6. Quantity released for distribution;

3.2.1.7.标签；

3.2.1.7. Labeling;

3.2.1.8. 批量生产的产品序列号；

3.2.1.8. Identifying serial number or batch production, and

3.2.1.9. 最终合格数量；

3.2.1.9. Final release of product.

3.3.检验和测试记录

3.3. Records of inspections and tests.

3.3.1.每个厂商应维护与关键产品质量属性直接相关的检验和测试结果的记录。

3.3.1. Each manufacturer shall maintain records of the results of inspections and tests set forth when they are directly related to critical

quality attributes of the product.

这些记录应包含验收标准、结果、使用的设备/仪器、日期和/或负责人签名电子版。

These records should include the acceptance criteria, the results, the

equipment / instrument used and date and or electronic signature of the person responsible.

第4章——项目/设计控制和产品主记录(PMR)

CHAPTER 4 - PROJECT/DESIGN CONTROL AND PRODUCT MASTER RECORD (PMR)

4.1.项目控制

4.1. Project Control

4.1.1.一般说明每个厂商应建立并维护产品设计控制程序，确保满足项目的规定要求。

4.1.1. General Instructions Each manufacturer shall establish and maintain procedures to control product design to ensure that the specified

requirements for the project are met.

4.1.2.项目规划与开发每个厂商应建立并维护项目计划，计划的内容包括项目和开发活动描述和说明，以及每个活动的负责人。项目计划应说明或参照项目开发活动，包括与开发活动有接触的不同组织组和技术组之间的互动。项目计划应根据项目开发进度进行评估、更新、审批。

4.1.2. Project planning and development. Each manufacturer shall establish and maintain plans that describe or indicate project and development activities, and the people responsible for each activity. The plans should describe or refer to the activities of project development, including any interaction between the various organizational and technical groups that may have some interface with it. The plans should be evaluated, updated and approved as project development progresses.

4.1.3.项目/设计输入每个厂商应建立并维护相关程序，确保产品相关要求适用于且满足预期用于，包括用户和患者的需求以及法律法规的要求。上述程序应包含对不完整、模棱两可或相互矛盾的要求进行确定和处理的机制。项目的输入数据应由指定的有资格人士进行记录、评估和审批。要求审批的内容，包括日期和/或负责人签名电子版必须记录在案。

4.1.3. Project/Design Input. Each manufacturer shall establish and maintain procedures to ensure that the requirements relating to a product

are appropriate and meet its intended use, including the needs of the

user and patient and legal requirements and regulations. The procedures shall include a mechanism that allows incomplete requirements, ambiguous or conflicting are identified and treated. The input data of a project should be documented, evaluated and approved by a qualified person designated. The approval requirements, including the date and or electronic signature of the approver should be documented.

4.1.4.设计验证每个厂商应建立并维护产品设计验证的程序。设计验证应由指定人员开展，确保相关数据满足项目对于输入数据的输出。设计验证的结果，包括经检查设计的鉴定、验证方法、验证日期、验证负责人姓名应记录在项目历史记录中。 Part c (e)设计评审 设计评审的结果应该记录在设计历史记录中

4.1.4. Design verification. Each manufacturer shall establish and maintain procedures for verification of product design. The design verification should be performed by a designated and shall ensure that the data meet the project's output to the input data. The results of the design verification, including identification of checked design, verification methods, date and name of the person responsible for the verification, shall be documented in the historical record of the project.

4.1.5.项目/设计输出每个厂商应定义并记录项目的数据输出，以评估输出数据是否满足设计要求中输入数据的要求。项目输出数据应满足输入数据的要求，且其中应包含验收标准，并确定对产品预期用途的关键的设计特征。在输出数据发布之前，应对以上各项进行记录、审查和批准。

4.1.5. Project/Design Output. Each manufacturer shall define and document the data output of the project in order to allow assessment of conformity to design requirements as input data. The output data of the project shall meet the requirements of the input data and should include acceptance criteria and identify design features that are essential

to the intended use of the product. These should be documented, reviewed and approved prior to release.

4.1.6.项目/设计审查每个厂商应建立并维护相关程序，确保项目结果的评估在项目开发的不同阶段得到适当的规划、开展和记录。而且相关程序还应确保与待审查项目阶段直接关联的所有职能代表以及相关领域的个人和专家都要参与在内。设计审查的结果应记录在项目历史记录中。

4.1.6. Project/Design Review. Each manufacturer shall establish and maintain procedures to ensure that the evaluations of the results of projects are planned, conducted and documented in the various stages of project development. The procedures shall ensure that representatives of all functions directly related to stage of the project that is being

reviewed, as well as individuals and experts in related fields required are involved. The results of design review should be documented in the historical record of the project.

4.1.7.项目转化每个厂商应建立并维护项目转化相关程序，确保产品设计正确地转化为生产规范。

4.1.7. Transfer project. Each manufacturer shall establish and maintain procedures to ensure that the product design is correctly translated

into production specifications.

4.1.8.设计确认每个厂商应建立并维护产品设计确认的程序。项目的确认应在首批生产批次或设备单元完成后，在预定的操作条件下开展。设计确认必须确保产品满足用户需求和使用指示，并且确认过程应包括对产品在实际或模拟使用条件下进行测试。设计确认必须

在适当情况下使用确认软件。设计确认的结果，包括经检查设计的鉴定、确认方法、确认日期、确认负责人的书面签名和电子版签名应记录在项目历史记录中。适用情况下应进行产品稳定性研究。

4.1.8. Design validation. Each manufacturer shall establish and maintain procedures for validating the product design. The validation of the

project should be carried out under predetermined operating conditions

on initial production batch or unit. The design validation must ensure

that the product meets user needs and indication for use and should include testing of the products in real or simulated conditions of use.

The design validation must

include the validation software when appropriate. The results of the design validation, including identification, methods, data and physical

or electronic signature of the responsible should be documented in the

historical record of the project. Should be conducted stability studies where applicable.

4.1.9.项目发布每个厂商应确保项目在指定人员批准之前不得投入生产。项目发布前，指定人员应审查项目所有历史记录，确保记录的完整性，同时保证最终设计版本与审批的计划相符。项目发布的过程，包括日期和/或负责人签名电子版必须记录在案。

4.1.9. Release project. Each manufacturer shall ensure that the project is not released for production until it is approved by the persons designated for such by the manufacturer. Appointees shall review all records required for the historical record of the project, to ensure it

is complete and that the final design is compatible with the approved

plans, prior to their release. This release, including date and or electronic signature of the person responsible, must be documented.

4.1.10.设计变更每个厂商应建立并维护设计变更实施前的鉴定、记录、确认、审查和批准程序，包括风险管理流程内的风险评估。

4.1.10. Design changes. Each manufacturer shall establish and maintain

procedures for the identification, documentation, validation, review and approval of design changes before their implementation, including a

risk assessment within the risk management process.

4.1.11.项目历史记录每个厂商应建立并维护每款产品的项目历史记录。项目历史记录应包含或参照所以必要记录，证明项目开发过程符合批准的设计计划以及本技术规范的要求。

4.1.11. Historical record of the project. Each manufacturer shall establish and maintain a historical record of the project for each product.

The historical record of the project shall contain or make reference to all records necessary to demonstrate that the project was developed

in accordance with the approved design plan and the requirements of this Technical Regulation.

4.2.产品主记录(PMR)/设备主记录(DMR)

4.2. Product Master Record (PMR)/Device Master Record (DMR)

4.2.1.每个厂商应维护产品主记录（器械主文档)。每种类型产品的器械主文档应包含或参照以下信息：

4.2.1. Each manufacturer shall maintain the product masters records (DMR). The DMR for each type of product should include or refer to the following information:

4.2.1.1.产品规范，包括设计、构成、配方、组件规范、软件设计规范及其源代码；

4.2.1.1. Product specifications, including their designs, composition,

formulation, component specifications, design specifications of the software and its source code;

4.2.1.2.生产流程规范，包括基础设施和设备的规范、生产方法和说明以及生产环境规范等；

4.2.1.2. Specifications of the production process, including specifications of infrastructure, equipment, methods and instructions for production and environmental specifications of production;

4.2.1.3.包装和标签规范，包括使用的方法和工艺。

4.2.1.3. Packaging and labeling specifications, including methods and

processes used;

4.2.1.4 检查和测试的程序和验收标准，以及

4.2.1.4 Procedures for inspection and testing, with their acceptance

criteria, and

4.2.1.5.安装、维护和维修的方法和程序。

4.2.1.5. Methods and procedures for installation, maintenance and servicing.

第5章——控制程序和生产流程

CHAPTER 5 - CONTROLS AND PRODUCTION PROCESS

5.1.一般说明

5.1. General Instructions

5.1.1.每个厂商应设计、执行、控制并监督所有生产流程，确保产品符合规范。由于制造流程的原因可能导致产品与规范产生偏差，厂商应建立并维护流程控制程序，说明必要的流程控制过程，确保产品符合规范。流程控制应包括：

5.1.1. Each manufacturer shall design, conduct, control and monitor all production processes to ensure that the product conforms to its specifications. Where can occur any deviation in the product specifications as a result of the manufacturing process, the manufacturer shall establish and maintain procedures to control process that describe any process controls necessary to ensure conformance to specifications. Process controls should include:

5.1.1.1.操作说明记录、定义和控制生产、安装和维护方式的标准操作程序和方法；

5.1.1.1. Documented instructions, standard operating procedures and methods that define and control the manner of production, installation and maintenance;

5.1.1.2.监督控制流程参数；

5.1.1.2. Monitoring and control of process parameters;

5.1.1.3.与技术标准、规范或参考标准的一致性，以及

5.1.1.3. Compliance with technical standards, codes or standards of reference, and

5.1.1.4.流程启动发布说明；

5.1.1.4. Instructions for process initiation release;

5.1.2.公司的设施必须经过适当的设计，确保能够进行所有操作和交换活动，或防止组成部分、生产材料、中间产品和成品受到污染，并保证以上各项的正确处理，包括配备充足的人员。

5.1.2. The company's facilities must be properly designed in order to

provide the performance of all operations, exchanges or prevent contamination of components, manufacturing materials, intermediate and finished products and ensure proper handling of them, including adequate flow of people.

5.1.3.环境控制每个厂商应为生产流程提供合适的环境条件，防止产品污染或对产品产生其他不利影响。监控已有环境控制程序是否正确执行，并做相关记录。

5.1.3. Environmental Control. Each manufacturer shall provide suitable

environmental conditions for production processes in order to prevent

contamination or other adverse effects on the product. The correct functioning of the established environmental controls should be monitored,

keeping the corresponding records.

5.1.3.1.清洁与消毒每个厂商应建立并维护适当的清洁和消毒程序，并制定满足制造流程规范要求的时间表。每个厂商应确保参与清洁和消毒的人员理解并掌握相关程序。

5.1.3.1. Cleaning and sanitizing. Each manufacturer shall establish and maintain appropriate procedures for cleaning and sanitizing, as well

as a schedule that satisfies the requirements of the specifications of

the manufacturing process. Each manufacturer shall ensure that personnel involved understand these procedures.

5.1.3.2.健康与个人卫生每个厂商应确保每个接触产品的员工或其他人员的穿着适合开展相应活动，保证员工的健康，并保持周围环境的清洁。如果在健康检查或监督观察中发现任何人员的健康状况可能会对产品产生影响，则上述人员应该停止操作，直至康复。每个厂商应指导员工向监督人员报告上述健康状况。

5.1.3.2. Health and personal hygiene. Each manufacturer shall ensure that employees and or others who are in contact with the product or your environment is clean, healthy and appropriately dressed for the activity to be performed. Any person who, by medical examination or supervisory observation, appearing to be at a health condition that may affect the product should be removed from operations until it is remedied.

Each manufacturer shall instruct its staff to report such conditions to supervisors.

5.1.3.3.个人习惯每个厂商应在特定区域内限制食用食物和饮料，避免对生产区域造成影响。

5.1.3.3. Personal habits. Each manufacturer shall limit the consumption of food and drinks at specific locations so as not to affect the production areas.

5.1.3.4.污染控制每个厂商应建立并维护污染控制程序，防止对设备、组成部分、制造材料、中间产品和成品受到清洁和消毒的污染，包括制造过程中产生的有害物质或污染物。

5.1.3.4. Control of contamination. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment, components, manufacturing materials, intermediate and finished products for cleaning and disinfecting materials, including hazardous substances or contaminants generated by the manufacturing process.

建立虫害控制程序，并且如果制造过程中使用了化学品，公司并需确保化学品不会对产品质量产生影响。

There should be a program of pest control and where chemicals are used,

the company must ensure that they do not affect product quality.

5.1.3.5.垃圾清除与化学污物排放对于垃圾、化学废料和副产品的处理和处置应符合现有法律规定。

5.1.3.5. Trash removal and chemicals sewage. The treatment and disposal of waste, chemical waste and by-products shall occur in accordance with the current laws.

5.1.3.6.如果制造过程中存在生物风险，应遵守生物安全标准。

5.1.3.6. Biological safety standards should be observed in cases where

there are biological risk.

5.1.4.员工职业健康每个厂商应确保遵守与员工职业健康相关的适用标准，包括员工根据工作流程的需要使用个人防护装备。

5.1.4. Worker occupational health. Each manufacturer shall ensure compliance with applicable standards related to the occupational health of

workers, including the use of personal protective equipment for the same, which is consistent with the work processes performed.

5.1.5.设备每个厂商应确保制造过程中使用的所有设备都经过适当设计、建造和安装，符合预期用途，有利于设备的维护、调整、清洁和使用。

5.1.5. Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process are suitable for the intended use and

properly designed, constructed and installed to facilitate maintenance,

adjustments, cleaning and use.

5.1.5.1.维修计划每个厂商应建立并维护一份维修和调整计划，并在适当的情况下制定设备清洁计划，确保满足所有制造规范的要求。确保维护人员和设备使用人员能够轻易获得设备的维护程序。对设备的维护活动，包括实现日期和负责人的鉴定进行记录。

5.1.5.1. Maintenance schedule. Each manufacturer shall establish and maintain a schedule for maintenance, adjustments and, when appropriate,

cleaning equipment, to ensure that all manufacturing specifications are being met. The maintenance program should be easily accessible to maintenance personnel and equipment use. Should be made a record of maintenance activities to the date of realization and identification of persons responsible.

5.1.5.2.调整每个厂商应确保在显眼的地方，或者需要定期调整的设备旁边张贴设备固有限制和可接受公差的相关信息，或者直接向相关负责人提供上述信息。

5.1.5.2. Adjustments. Each manufacturer shall ensure that any inherent

limitations or acceptable tolerances are posted in a conspicuous place

at or near the equipment requiring periodic adjustments or are readily

available to the personnel in charge of these adjustments.

5.1.5.3.制造材料每个厂商必须建立并维护使用和清除制造材料的程序，确保上述材料从产品附近清除，或者将材料限制在特定数量，从而不会对产品产生不利影响。

5.1.5.3. Manufacturing materials. Each manufacturer must establish and

maintain procedures for the use and removal manufacturing materials, to ensure that such materials be removed from the product or limited to

a specified amount that does not adversely affect the quality of the product.

5.1.6.制造特殊流程应根据已有的程序和指导方针来执行，确保符合相关规范要求。产品历史记录中应记录产品的关键参数。

5.1.6. Special Processes shall be conducted in accordance with procedures and guidelines established to ensure conformance to specifications.

Critical parameters should be monitored and recorded in the historical

record of product.

5.2.包装和标签粘贴控制及使用说明

5.2. Controls packaging, labeling and instructions for use

5.2.1.产品包装每个厂商应建立产品包装程序，以防止产品在处理、储存、搬运或销售过程中变质、损坏或污染。

5.2.1. Product packaging. Each manufacturer shall establish procedures for the packaging of goods so as to protect the product from deterioration, damage or contamination during processing steps, storage, handling and distribution.

5.2.2.产品标签粘贴

5.2.2. Product labeling

5.2.2.1.每个厂商应建立并维护产品标签粘贴程序，确保标签完整性，防止标签、使用说明、包装材料和识别标识的混淆。

5.2.2.1. Each manufacturer shall establish and maintain procedures to

ensure the integrity and avoid accidental mixing of labels, instructions for use, packaging materials, and identification labels.

5.2.2.2.每个厂商应确保标签在设计、印刷、张贴（如适用）以及在产品处理、储存、搬运和使用过程中保持清晰可辨。

5.2.2.2. Each manufacturer shall ensure that the labels are designed,

printed and, if applicable, applied to remain legible and attached to

the product during processing steps, storage, handling and use.

5.2.2.3.标签和使用说明的检查在授权人员对标签和使用说明进行审查，确定其符合本技术规范相关信息之前不得投入使用。标签和使用说明的审批，包括日期、名称、负责人书面签名和电子版签名必须记录在产品的历史记录中。

5.2.2.3. Inspection of the labels and instructions for use. The labels

and instructions for use shall not be released for use until an authorized person has reviewed its compliance regarding information contained therein. The approval, including date, name and physical or electronic signature of the person responsible, must be documented in the historical record of the product.

5.3.检查与测试

5.3. Inspection and testing

5.3.1.一般说明每个厂商应建立并维护检查、测试或其他验证方法的相关程序，确保其在整个制造过程中符合规定的要求。收到组成部分、制造材料时，以及在中间生产阶段的验收活动结果，以及成品的最终验收结果应进行记录，其中包括验收结果（接受或拒绝）。

5.3.1. General instructions. Each manufacturer shall establish and maintain procedures of inspection, testing or other means of verification

to ensure compliance with the requirements specified in the full chain

of manufacturing. The results of the activities of acceptance upon receipt of components and manufacturing materials as well as intermediate

production stages and final acceptance of the finished product shall be documented, including its completion (acceptance or rejection).

5.3.2.每项活动的权限和职责由厂商确定。

5.3.2. The authority and responsibility for such activities shall be defined by the manufacturer.

5.3.3.收到的组成部分和制造材料，以及中间产品和退还的产品在检查证明其符合相关标准之前不得使用或进行处理。每个厂商应建立并维护相关程序，在检查、测试或其他检验完成并记录之前，对组成部分、制造材料、中间产品和退还产品进行保存。

5.3.3. Components and manufacturing materials received, as well as components, intermediate products, and returned products should not be used or processed until it is checked for conformance to requirements. Each manufacturer shall establish and maintain procedures for retaining

components, manufacturing materials, intermediates, and products returned until the inspections, tests, or other established checks have been completed and documented.

5.3.4.部分或器械主文档完成之前，且记录档案和相关数据由指定人员审查之前不得对成品进行放行，确保所有验收标准都得到满足。产品的放行，包括日期和/或负责人签名电子版必须记录在案。

5.3.4. The finished products should not be freed until the activities

specified in the PMR/DMR have been completed and until the documentation and associated data have been reviewed by a designated person to ensure that all acceptance criteria have been met. The release, includin

g the date and or electronic signature of the person responsible, must

be documented.

5.4.检验、测试和量具的要求

5.4. Inspection, test and measuring equipment.

5.4.1.每个厂商应确保所有测量和测试设备，包括机械设备、自动设备或电子设备适用于预期用途，且能够生成有效结果。每个厂商应建立并维护相关程序，确保对设备进行定期校准、检查和控制。对测量设备进行鉴定，确定设备的校准状态。

5.4.1. Each manufacturer shall ensure that all measuring and test equipment, including mechanical equipment, automated or electronic, is suitable for the purposes for which it is intended and be able to produce

valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected and controlled. The measuring equipment shall be identified to enable the calibration status to be determined.

5.4.2.校准每个厂商应建立并维护校准程序，包括精度和准确度的特定指南和限制以及未达到指定精度和准确度时的纠正措施指示。

5.4.2. Calibration. Each manufacturer shall establish and maintain calibration procedures that include specific guidelines and limits of precision and accuracy, as well as prescriptions for corrective action when the limits of precision and accuracy are not achieved.

校准操作应由有相关教育和培训背景，并具备所需实践经验的人员来执行。

Calibration should be performed by personnel who have education, training, practice and experience needed.

5.4.3.校准标准每个厂商应建立并维护测量设备的校准标准，这些设备应该能够追溯国家标准或国家标准的相关官员。如果没有适用的标准，厂商应自行建立并维护适当标准。

5.4.3. Calibration standards. Each manufacturer shall establish and maintain calibration standards for measuring equipment that are traceable to national or international standards officers. If there is no applicable standard is available, the manufacturer shall establish and maintain its own pattern.

5.4.4.校准记录每个厂商应确保对校准测量结果获得日期、操作负责人和下一校准操作日期进行记录。校准记录由厂商负责，并确保使用设备或负责校准的人员能够获得相关记录。

5.4.4. Calibration records. Each manufacturer shall ensure that records are kept of the dates of calibration measurements obtained, the employee in charge of this task and the next date for this operation. Records shall be kept by the manufacturer and should be available for staff using this equipment and those responsible for the same calibration.

5.4.5.维护每个厂商应建立并维护相关记录，确保在测试设备、检查设备和测量设备使用过程中进行必要保护，以保持设备的精确度和适用性。

5.4.5. Maintenance. Each manufacturer shall establish and maintain procedures to ensure that the handling, preservation and care of test, inspection and measurement equipment to be made in order to preserve its

accuracy and suitability.

5.4.6.设施每个厂商应保护相关设施以及检查设备、测试设备和测量设备，包括测试硬件和软件，避免设备调整过程中对校准状态产生破坏。

5.4.6. Facilities. Each manufacturer shall protect facilities and inspection, test and measurement equipment, including test hardware and software, from adjustments that would invalidate the calibration.

5.4.7.厂商应建立相关程序，在发现测试设备和测量设备不符合标准时，就这种情况对之前的测量结果的影响进行评估。评估的结果应进行记录。

5.4.7. The manufacturer shall establish procedures to assess the impact of the previous measuring results when non-compliances observed in test and measurement equipment. The result of the assessment should be

documented.

5.5.确认

5.5. Validation

5.5.1.特殊流程必须根据已建立的条款进行确认。确认的结果，包括日期和负责人的鉴定批准应记录在案。

5.5.1. Special processes must be validated according to previously established protocols. The results of validations, including the date and

identification of the person responsible for its approval, shall be recorded.

5.5.2.可能对产品质量或质量体系带来不利影响的分析方法、辅助系统支持过程或环境控制、自动信息系统和软件必须进行确认。

5.5.2. Analytical methods, auxiliary systems support process or environmental control, automated information systems and software that may adversely affect the quality of the product or the quality system must

be validated.

5.5.3.厂商应建立程序，对经过确认的流程、分析方法、流程控制的辅助支持系统，或环境、信息系统和自动软件进行定期检查，并在适用情况下确定重新确认的频率。

5.5.3. The manufacturer shall establish procedures to periodically check your processes, analytical methods, auxiliary support systems for process control or environment, information systems and automated software validated and, where applicable, establish the frequency for revalidation.

5.6.变更控制

5.6. Change Control.

厂商应建立变更控制程序，以追踪可能对产品质量产生影响的辅助系统、软件、设备、流程、方法以及其他方面的变更，包括风险管理流程内的风险评估。

The manufacturer shall establish a procedure to control changes in order to track changes in auxiliary systems, software, equipment, processes, methods or other changes that may affect product quality, including a risk assessment within the risk management process .

5.6.1.变更控制程序应说明需要采取的措施，包括确定是否有必要重新进行资格评定或重新验证（若适用）。

5.6.1. The procedure should describe the actions to be taken, including, when appropriate, the need for re-qualification or re-validation.

5.6.2.实施变更之前，应对变更情况进行正式申请、记录和审批。

5.6.2. Changes should be formally requested, documented and approved before implementation.

第6章——搬运、储存、销售和追踪

CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACKING

6.1.搬运

6.1. Handling

6.1.1.每个厂商应建立并维护相关程序，确保在搬运过程中不会出现影响组成部分、制造材料、中间产品、成品和样品质量控制的变化（变更）、损坏、编制或其他不良事件。

6.1.1. Each manufacturer shall establish and maintain procedures to ensure that inversions (changes), damage, deterioration or other adverse

events affecting the components, manufacturing materials, intermediate

products, finished products and samples for quality control does not occur during any stage of the handling.

6.1.2.每个厂商应建立并维护相关程序，对组成部分、制造材料、中间产品和成品的合格性进行确定，确保只有经过正式批准的组成部分、材料或产品才能进行使用或销售。

6.1.2. Each manufacturer shall establish and maintain procedures to identify the conformity of components, manufacturing materials, intermediate products and finished products to ensure that only those duly approved, are used or distributed.

6.1.3.同时还必须确保当适用组成部分、制造材料、中间产品或成品的使用质量或条件随时时间发生恶化时，制定的程序应有相关规定避免对这些恶化产品进行使用或销售。

6.1.3. The procedures must ensure that when the quality or condition of the use of a suitable component manufacturing material, intermediate

product or finished product can deteriorate over time, they are not used or distributed.

6.1.4.相关程序应确保首先使用或销售即将过保质期的组成部分、制造材料、中间产品或成品，并且防止使用或销售过期的组成部分、材料和产品。

6.1.4. The procedures shall ensure that components, manufacturing materials, intermediate or finished products closer to the expiration are

distributed or used in the first place, and that one out-date are not

distributed or used.

6.2.储存

6.2. Storage

6.2.1.每个厂商应建立并维护相关标准，对组成部分、制造材料、中间产品，成品和样品的质量控制进行鉴定，防止变化（调换）。在储存周期内，上述组成部分、材料和产品的储存环境应能够避免引起损坏、变质，防止产生其他不良事件。

6.2.1. Each manufacturer shall establish and maintain procedures for identifying components, manufacturing materials, intermediate products,

finished products and samples for quality control in order to prevent

inversions (exchanges). These should be stored in physical and environmental conditions that prevent damage, deterioration or other adverse

effects during the period in which remain stored.

6.3.销售

6.3. Distribution

6.3.1.每个厂商应维护产品的销售记录，其中包括：

6.3.1. Each manufacturer shall maintain distribution records which include or refer to:

6.3.1.1.承销人的姓名和地址；

6.3.1.1. Name and address of the consignee;

6.3.1.2.装运产品的鉴定和数量，附上装运日期，以及

6.3.1.2. Identification and quantity of products shipped with shipment

date, and

6.3.1.3.用于产品追溯的数字控制方法。

6.3.1.3. Any numerical control used for traceability.

6.4.鉴定与追溯

6.4. Identification and traceability

6.4.1.每个厂商应建立并维护相关程序，在储存、生产、销售和安装过程中对组成部分、制造材料、中间产品和成品进行鉴定，防止混淆并确保订单正确执行。

6.4.1. Each manufacturer shall establish and maintain procedures for the identification of components, manufacturing materials, intermediates and finished products during all phases of storage, production, distribution and installation to avoid confusion and to ensure correct order fulfillment.

6.4.2.每个厂商应鉴定各个产品单元、批次的序号和批号。鉴定过程应记录在产品历史记录中。

6.4.2. Each manufacturer shall identify each unit, lot or batch of products with a serial number or lot. This identification shall be recorded in the historical record of the product.

6.5.组成部分和不合格产品

6.5. Components and non-compliant products

6.5.1.每个厂商应建立并维护相关程序，确保不符合要求的组成部分、制造材料、中间产品、成品或退回产品无意被使用或安装。上述程序应包括不合格的组成部分、制造材料、中间产品和成品的鉴定、记录、评估、分离、处理要求。

6.5.1. Each manufacturer shall establish and maintain procedures to ensure that components, manufacturing materials, intermediate products,

finished products and returned products that do not comply with the requirements are not used or installed inadvertently. The procedures shall include requirements for the identification, documentation, evaluation, segregation and disposition about components, manufacturing materials, intermediates and finished products not complying.

不合格产品的评估应包含调查的必要性，以及对相关个人和/或机构的通知。

Assessment of non-compliance should include the need for investigation

and notification to individuals and or organizations involved in non-compliance.

评估和调查的结果应进行记录。

The results of evaluations and any investigation should be recorded.

6.5.2.对组成部分、制造材料、中间产品、成品和返回的不合格产品的审查职责和处置权限必须进行规定。已有的程序中应说明审查和处置过程。处置的过程应进行记录，同时记录负责人的判断理由、书面签名和电子版签名。

6.5.2. Responsibility for review and authority for disposition about components, manufacturing materials, intermediate products, finished products and returned nonconforming must be defined. The review process

and disposition must be described in established procedure. The disposition should be documented and should be kept record of justification

and physical or electronic signature (s) responsible (s) for the same.

是否授予使用许可应根据通过技术上合理的风险评估来确定。

In case of a use permit, the decision should be based on risk assessment technically justifiable.

6.5.3.每个厂商应建立并维护返工程序，对返工后的中间产品和成品进行重新检查和评估，确保他们满足原有的规范。产品返工和重新评估的相关活动，包括返工中的问题应记录在产品历史记录中。

6.5.3. Each manufacturer shall establish and maintain procedures for rework, reinspection and revaluation of intermediate or finished product after rework, to ensure that they meet original specifications. Activities related to rework and reevaluation of the product, including the same problems from the rework should be documented in the historical

record of product.

第7章——预防措施和纠正措施

SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS

7.1.纠正措施及预防措施

7.1. Corrective and preventive actions.

7.1.1.每个厂商应建立并维护与以下各项相关的程序：

7.1.1. Each manufacturer shall establish and maintain procedures

for:

7.1.1.1.分析流程、操作、质量审计报告、质量记录、维修记录、投诉、返回产品和其他质量数据，以确定产品、流程或质量体系相关不合格情况的现有原因和潜在原因。在适用情况下，根据有效的统计方法进行分析，以检测重复发生的质量问题；

7.1.1.1. Analyzing processes, work operations, quality audit reports,

quality records, service records, complaints, returned product, and ot

her sources of quality data to identify existing and potential causes

of nonconformities relating to product, process or quality system. Where applicable, the analysis should be based on valid statistical technique to detect recurring quality problems;

7.1.1.2.调查产品、流程或质量体系相关不合格情况发生的原因；

7.1.1.2. Investigating the cause of nonconformities relating to product, process and quality system;

7.1.1.3.确定并执行必要措施，防止发生不合格问题，处理不合格情况并防止其再次发生。

7.1.1.3. Identify and perform the necessary actions to prevent the occurrence, fix what happened and prevent recurrence of non-conformities;

7.1.1.4.验证或确认纠正措施的有效性，并确保采取的措施不会对产品产生不利影响。为此，在适用情况下，必须根据以下变更控制和确认规定实施变更；

7.1.1.4. Verify or validate the effectiveness of the corrective action and ensure that it does not adversely affect the product. For this purpose, any changes made, where applicable, shall observe the following change control and validation protocols established;

7.1.1.5.记录与纠正措施和预防措施有关的活动；

7.1.1.5. Record activities related to corrective and preventive actions;

7.1.1.6.确保质量问题或不合格产品相关的信息适当地传达给直接参与产品质量维护的人员，防止类似问题再次发生；

7.1.1.6. Ensure that information about quality problems or nonconforming product are properly disseminated to those directly involved in the maintenance of product quality and to prevent such problems from occurring;

7.1.1.7.将交已确定质量问题以及预防措施和纠正措施的相关信息提交给行政管理层进行了解和监督，并在适用情况下提交给卫生主管机构；

7.1.1.7. Submitting relevant information on identified quality problems and preventive and corrective actions to executive management to knowledge and monitoring, as well as the competent health authority, where applicable;

7.1.1.8.确定产品已经销售的情况下产品召回和其他措施。

7.1.1.8. Determine product recalls and other field actions that are relevant in the case of products already distributed.

7.2.投诉管理

7.2. Complaints management.

7.2.1.每个厂商应建立并维护相关程序，以接受、检查、评估、调查并记录各种投诉。以上程序应确保：

7.2.1. Each manufacturer shall establish and maintain procedures to receive, examine, evaluate, investigate and file complaints. Such procedures shall ensure that:

7.2.1.1.正式指定的单位能够接受、检查、评估、调查并记录各种投诉；

7.2.1.1. Complaints are received, documented, examined, evaluated, investigated and filed by a formally designated unit;

7.2.1.2.在适用情况下，将投诉告知健康主管机关；

7.2.1.2. Where applicable, the complaints are notified to the competent health authority;

7.2.1.3.对投诉进行检查，确定是否有调查必要。如果未对投诉事宜进行调查，相关单位应进行记录维护，说明未进行调查的原因和相关责任人的姓名。

7.2.1.3. Complaints are examined to see if an investigation is necessary. When an investigation is not done, the unit shall maintain a record that includes the reason why the investigation was not conducted and

the name of the responsible decision not to investigate;

7.2.1.4.每个厂商应检查、评估并调查与可能不合格产品相关的所有投诉。而对于死亡、受伤或公共健康威胁的索赔，必须立即审查、评估和调查。

7.2.1.4. Each manufacturer shall examine, evaluate and investigate all

complaints involving possible non-conformity of the product. Any claim

for death, injury, or threat to public health should be immediately reviewed, evaluated and investigated.

7.2.1.5.如果调查已经进行，必须进行以下事项的记录：