医疗器械生产质量管理规范-中英文对照版

国家食品药品监督管理总局关于发布医疗器械生产质量管理规范的公告 （2014年第64号） CFDA Announcement on Releasing GoodManufacturing Practice for Medical Devices ([2014] No. 64) 2014年12月29日发布 Released on December 29, 2014 国家食品药品监督管理总局 China Food and Drug Administration 公　告 Announcement 2014年　第64号 [2014] No. 64 关于发布医疗器械生产质量管理规范的公告 Announcement on Releasing Good Manufacturing Practice for Medical Devices 为加强医疗器械生产监督管理，规范医疗器械生产质量管理，根据《医疗器械监督管理条例》（国务院令第650号）、《医疗器械生产监督管理办法》（国家食品药品监督管理总局令第7号），国家食品药品监督管理总局组织修订了《医疗器械生产质量管理规范》，现予以发布。 In order to enhance the supervision and administration of, and standardize thequality management of, the medical devices manufacturing, and in accordancewith the Regulations for theSupervision and Administration of Medical Devices ( StateCouncil Order No. 650) and the Provisionfor Supervision of Medical DevicesManufacturing (CFDA Order No. 7), China Food and Drug Administration(“CFDA”) organized the revision of the GoodManufacturing Practice for Medical Devices, and which is hereby released. 特此公告。 It is hereby notified! 附件：医疗器械生产质量管理规范 Annex: Good Manufacturing Practice for Medical Devices 食品药品监管总局 China Food and Drug Administration 2014年12月29日 December 29, 2014 附件 Annex 医疗器械生产质量管理规范 Good Manufacturing Practice for Medical Devices 第一章 总则 Chapter I General Provisions 第一条　为保障医疗器械安全、有效，规范医疗器械生产质量管理，根据《医疗器械监督管理条例》（国务院令第650号）、《医疗器械生产监督管理办法》（国家食品药品监督管理总局令第7号），制定本规范。 Article 1 With a view to ensuring the safety and effectiveness of medical devices and standardizing the management on quality of medical devices manufacturing, the Good Manufacturing Practice for Medical Devices (“GMP”) is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices (State Council Order No.650) and the Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7). 第二条　医疗器械生产企业（以下简称企业）在医疗器械设计开发、生产、销售和售后服务等过程中应当遵守本规范的要求。 Article 2 Medical device manufacturers (hereinafter referred to as “manufacturers”) shall comply with the requirements set out in the GMP when designing and developing, manufacturing and selling medical devices, as well as providing after-sales services. 第三条　企业应当按照本规范的要求，结合产品特点，建立健全与所生产医疗器械相适应的质量管理体系，并保证其有效运行。 Article 3 Manufacturers shall establish and improve the quality management system adapted to the medical devices manufactured in combination with product features according to the requirements in the GMP and ensure its effective operation. 第四条　企业应当将风险管理贯穿于设计开发、生产、销售和售后服务等全过程，所采取的措施应当与产品存在的风险相适应。 Article 4 Manufacturers shall conduct risk management through the whole process of design and development, manufacture, sales and after-sales service and take the measures adapted to product risks. 第二章　机构与人员 Chapter II Institution and Personnel 第五条　企业应当建立与医疗器械生产相适应的管理机构，并有组织机构图，明确各部门的职责和权限，明确质量管理职能。生产管理部门和质量管理部门负责人不得互相兼任。 Article 5 Manufacturers shall establish the regulatory agency adapted to medical device manufacture with the organizational chart which clarifying the responsibilities and authorities of all divisions as well as quality function &responsibilities. Neither the head of manufacture management department nor the head of quality management department shall hold a concurrent post with each other. 第六条　企业负责人是医疗器械产品质量的主要责任人，应当履行以下职责： Article 6 The principal of manufacturers is the main responsible person of the quality of medical devices and shall fulfill the following responsibilities: （一）组织制定企业的质量方针和质量目标； (1) Organize the formulation of quality policy and quality objectives of manufacturers; （二）确保质量管理体系有效运行所需的人力资源、基础设施和工作环境等； (2) Ensure the humanr esources, infrastructures and working environment required for the effective operation of quality management system, etc.; （三）组织实施管理评审，定期对质量管理体系运行情况进行评估，并持续改进； (3) Organize the management review and carry out periodical evaluation on the operation of quality management system, and continuously improve it; （四）按照法律、法规和规章的要求组织生产。 (4) Organize the manufacture in accordance with laws and regulations. 第七条　企业负责人应当确定一名管理者代表。管理者代表负责建立、实施并保持质量管理体系，报告质量管理体系的运行情况和改进需求，提高员工满足法规、规章和顾客要求的意识。 Article 7 The principal of the manufacturer shall appoint a management representative. Such management representative shall be responsible for establishing, implementing and maintaining the quality management system, report the working conditions and improvement needs of the quality management system, and enhance the employees’ awareness of complying with the regulations, rules and customer requirements. 第八条　技术、生产和质量管理部门的负责人应当熟悉医疗器械相关法律法规，具有质量管理的实践经验，有能力对生产管理和质量管理中的实际问题作出正确的判断和处理。 Article 8 The head of technical, manufacture and quality management department shall be familiar with laws and regulations related to medical devices, have practical experiences on quality management and be able to make correct judgment and handling for the practical problems in manufacture management and quality management. 第九条　企业应当配备与生产产品相适应的专业技术人员、管理人员和操作人员，具有相应的质量检验机构或者专职检验人员。 Article 9 Manufacture