| Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
| (No. 33) | | （第33号） |
| The Measures for the Administration of the Standards for Medical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, are hereby issued and shall come into force on July 1, 2017. | | 《医疗器械标准管理办法》已于2017年2月21日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2017年7月1日起施行。 |
| Director: Bi Jingquan | | 局长：毕井泉 |
| April 17, 2017 | | 2017年4月17日 |
| Measures for the Administration of the Standards for Medical Devices | | 医疗器械标准管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of promoting scientific and technological progress, guaranteeing the safety and effectiveness of the medical devices, improving the level of health guarantee, and strengthening the administration of the standards for medical devices, these Measures have been developed in accordance with the Standardization Law of the People's Republic of China, the Regulation for the Implementation of the Standardization Law of the People's Republic of China, the Regulation on the Supervision and Administration of Medical Devices and other laws and regulations. | | 第一条 为促进科学技术进步，保障医疗器械安全有效，提高健康保障水平，加强医疗器械标准管理，根据《中华人民共和国标准化法》《中华人民共和国标准化法实施条例》和《医疗器械监督管理条例》等法律法规，制定本办法。 |
| Article 2 For the purposes of these Measures, “standards for medical devices” means the unified technical requirements developed and updated from time to time by the China Food and Drug Administration (“CFDA”) according to the functions, issued under the legal procedures, and followed in the research and manufacturing, production, business operation, use, supervision and administration, etc. of the medical devices. | | 第二条 本办法所称医疗器械标准，是指由国家食品药品监督管理总局依据职责组织制修订，依法定程序发布，在医疗器械研制、生产、经营、使用、监督管理等活动中遵循的统一的技术要求。 |
| Article 3 The development, revision, implementation, supervision and administration of the standards for medical devices within the territory of the People's Republic of China shall be conducted under the laws and administrative regulations and the provisions of these Measures. | | 第三条 在中华人民共和国境内从事医疗器械标准的制修订、实施及监督管理，应当遵守法律、行政法规及本办法的规定。 |
| Article 4 The standards for medical devices shall be classified into mandatory standards and recommended standards according to their effectiveness. | | 第四条 医疗器械标准按照其效力分为强制性标准和推荐性标准。 |
| The technical requirements guaranteeing the human health and life safety shall be developed as mandatory national standards and mandatory industrial standards for medical devices. | | 对保障人体健康和生命安全的技术要求，应当制定为医疗器械强制性国家标准和强制性行业标准。 |
| The technical requirements meeting the basic universal needs, supporting the mandatory standards, playing a leading role in the medical devices industry and meeting other needs may be developed as recommended national standards and recommended industrial standards for medical devices. | | 对满足基础通用、与强制性标准配套、对医疗器械产业起引领作用等需要的技术要求，可以制定为医疗器械推荐性国家标准和推荐性行业标准。 |
| Article 5 The standards for medical devices shall be divided into basic standards, management standards and product standards according to the regulating objects. | | 第五条 医疗器械标准按照其规范对象分为基础标准、方法标准、管理标准和产品标准。 |
| Article 6 The CFDA shall lawfully develop the plans for the standards for medical devices, establish a working system for the administration of the standards for medical devices, and improve the system for the administration of the standards for medical devices. | | 第六条 国家食品药品监督管理总局依法编制医疗器械标准规划，建立医疗器械标准管理工作制度，健全医疗器械标准管理体系。 |
| Article 7 Enterprises, social organizations, educational research institutions and individuals shall be encouraged to extensively participate in the development and revision of the standards for medical devices, and supervise the implementation of the standards for medical devices. | | 第七条 鼓励企业、社会团体、教育科研机构及个人广泛参与医疗器械标准制修订工作，并对医疗器械标准执行情况进行监督。 |
| Article 8 Participation in the international standardization activities and the development and adoption of the international standards for medical devices shall be encouraged. | | 第八条 鼓励参与国际标准化活动，参与制定和采用国际医疗器械标准。 |
| Article 9 The CFDA shall commend and reward the organizations and individuals that have made outstanding achievements in work of standards for medical devices under the relevant provisions of the state. | | 第九条 国家食品药品监督管理总局对在医疗器械标准工作中做出显著成绩的组织和个人，按照国家有关规定给予表扬和奖励。 |
| Chapter II Standards Management Duties | | 第二章 标准管理职责 |
| Article 10 The CFDA shall perform the following functions: | | 第十条 国家食品药品监督管理总局履行下列职责： |
| (1) It shall organize the implementation of the relevant laws and regulations on the administration of the standards for medical devices and develop a working system for the administration of the standards for medical devices. | | （一）组织贯彻医疗器械标准管理相关法律、法规，制定医疗器械标准管理工作制度； |
| (2) It shall organize the development of the plans for the standards for medical devices and develop annual work plans for the development and revision of standards. | | （二）组织拟定医疗器械标准规划，编制标准制修订年度工作计划； |
| (3) It shall lawfully organize the development and revision of the standards for medical devices and issue the industrial standards for medical devices. | | （三）依法组织医疗器械标准制修订，发布医疗器械行业标准； |
| (4) It shall direct and supervise the administration of the standards for medical devices. | | （四）依法指导、监督医疗器械标准管理工作。 |
| Article 11 The National Institutes for Food and Drug Control (“NIFDC”) of the CFDA shall perform the following functions: | | 第十一条 国家食品药品监督管理总局医疗器械标准管理中心（以下简称“医疗器械标准管理中心”）履行下列职责： |
| (1) organize the research on the system of the standards for medical devices, and develop the draft plans for the standards for medical devices and the suggestions for the annual work plans for the development and revision of the standards; | | （一）组织开展医疗器械标准体系的研究，拟定医疗器械标准规划草案和标准制修订年度工作计划建议； |
| (2) lawfully manage the development and revision of the standards for medical devices; | | （二）依法承担医疗器械标准制修订的管理工作； |
| (3) lawfully manage the medical device standardization technical committee; | | （三）依法承担医疗器械标准化技术委员会的管理工作； |
| (4) organize the publicity and training of the standards for medical devices; | | （四）承担医疗器械标准宣传、培训的组织工作； |
| (5) organize the investigation and research on the implementation of the standards, and coordinate with and resolve the major technical problems in the implementation of the standards; | | （五）组织对标准实施情况进行调研，协调解决标准实施中的重大技术问题； |
| (6) undertake the relevant work of international medical device standardization activities and foreign cooperation and exchange; | | （六）承担医疗器械国际标准化活动和对外合作交流的相关工作； |
| (7) undertake the informatization of the standards for medical devices and organize the publication of the standards for the medical device industry; and | | （七）承担医疗器械标准信息化工作，组织医疗器械行业标准出版； |
| (8) undertake other management work of the standards assigned by the CFDA. | | （八）承担国家食品药品监督管理总局交办的其他标准管理工作。 |
| Article 12 The CFDA shall, according to the needs of the work of medical device standardization, lawfully form a medical device standardization technical committee, subject to approval. | | 第十二条 国家食品药品监督管理总局根据医疗器械标准化工作的需要，经批准依法组建医疗器械标准化技术委员会。 |
| The medical device standardization technical committee shall perform the following functions: | | 医疗器械标准化技术委员会履行下列职责： |
(1) carry out the work of research on the standards for medical devices and offer the opinions for the development plans for the standards and the standard system in the professional field;
．．．．．． | | （一）开展医疗器械标准研究工作，提出本专业领域标准发展规划、标准体系意见；
．．．．．． |
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