(英文版)医疗器械临床试验质量管理规范方案.doc

FG-20160601025 Good Clinical Practice for Medical Devices (No. 25 Order of CFDA and NHFPC) Order of China Food and Drug Administration and National Health and Family Planning Commission of China No. 25 Adopted at the meeting of CFDA and NHFPC, this practice is hereby promulgated, and shall take effect as of June 1, 2016.? 　　　　　　　　　　　　　　　　　　　　　　　　　　　 Director? Bi Jingquan Director Li Bin March 1, 2016 Good Clinical Practice for Medical Devices Chapter 1 General provisions Article 1 The Practice is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices in order to further strengthen the management of clinical trials of medical devices, protect the rights and benefits of trial subjects and assure the clinical trial procedure standard, truthful, scientific, reliable and traceable. Article 2 All the clinical trials of medical devices within the territory of the Peoples Republic of China shall be conducted according to the practice. The Practice covers the whole procedure of clinical trial of medical devices, including the protocol design, conduction, monitoring, audit, inspection, collection of data, record, analysis and summary and report of clinical trial, etc. Article 3 Clinical trial of medical devices mentioned in this Practice refers to the process of confirming and verifying the safety and efficacy of the medical device intended to apply registration under normal condition in qualified clinical trial institutions of medical devices. Article 4 Clinical trials of medical devices shall comply with the principle of legal, ethic and science. Article 5 Food and drug regulatory authority above province level are responsible for the supervision and management of clinical trails of medical devices. The competent department of National Health and Family Planning Commission shall strengthen the management of clinical trails of medical devi