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

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 ANDPRODUCTS 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 ofGMC 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 BRS APARECIDO BARBANO=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 ANDPRODUCTS 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 BCHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM2.1. 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 DCHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY3.1. 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 CCHAPTER 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 partGCHAPTER 5 - PROCESS AND PRODUCTION CONTROLS 5.1. 总则5.1. General Instructions5.2. 包装，标签和使用说明书 partL5.2. Controls packaging, labeling and instructions for use5.3. 检验和测试 Part H5.3. Inspection and testing5.4.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 TRACEABILITY6.1.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 ACTIONS7.1.纠正和预防措施7.1. Corrective and Preventive Actions 7.2.投诉的管理7.2. Management of complaints7.3.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 SERVICING8.1.安装8.1. Installation8.2.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=第1章总则CHAPTER 1 - GENERAL PROVISIONS1.1适用性1.1 - Applicability1.1.1.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 during 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 SYSTEM2.1.总则2.1. General Provisions2.1.1.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, and2.1.1.2.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 responsibility2.2.1.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 described 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 v