《英文版医疗器械临床试验质量管理基础规范》由会员分享，可在线阅读，更多相关《英文版医疗器械临床试验质量管理基础规范（45页珍藏版）》请在金锄头文库上搜索。
1、FG-0601025Good 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 ChinaNo. 25Adopted at the meeting of CFDA and NHFPC, this practice is hereby promulgated, and shall take effect as of
2、 June 1, .Director Bi Jingquan Director Li Bin March 1, Good Clinical Practice for Medical DevicesChapter 1 General provisionsArticle 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
3、 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
4、 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
5、 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 s
6、hall 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 stren
7、gthen the management of clinical trails of medical devices withinthescopeofitsduties.Food and drug regulatory authority and the competent department of NHFPC shall establish the information notification system on quality management of medical device clinical trials and strengthen the information not
8、ification on the approval for conducting clinical trial of Class III medical devices and the medical devices listed in the management catalog of largemedicalequipment collocationinChina and the data of the supervision and management on relevant clinical trial.Chapter II Preparation before clinical t
9、rialsArticle 6 There should be sufficient scientific basis and clear trial purpose to conduct clinical trials of medical devices, and the expected benefits and risks to the health of subjects and public shall be weighed, the expected benefits should exceed the possible damage.Article 7 Before clinic
10、al trial, the sponsor shall complete the pre- clinical study of investigational medical devices, including the design of products (structure and composition, working principle and mechanism of action, intended use, application scope and applicable technical requirements) and quality inspection, anim
11、al trial and analysis report, etc, and the results shall support the clinical trial. The results of quality inspection include report of self-inspection and the qualified report for registration inspection issued by a qualified inspection agency within one year.Article 8 Before clinical trial, the s
12、ponsor shall prepare adequate investigational medical devices. The development of investigational medical devices shall meet relevant requirements of quality management system of medical devices.Article 9 Clinical trials of medical devices shall be conducted in two or more than two clinical trial in
13、stitutions of medical devices. The selected trail institution shall be qualified clinical trial institution of medical devices and the facilities and conditions shall meet the requirements for conducting clinical trials safely and effectively. The investigator should have the professional expertise,
14、 qualifications and ability to undertake the clinical trial and should have been trained.Administrative measures for the qualificationrecognition of clinical trial institutions of medical devicesshallbeformulatedseparatelyby China Food and Drug Administration and National Health and Family Planning
15、Commission of China.Article 10 Before clinical trial, the sponsor, clinical trial institution and investigator shall make awrittenagreement on trial design, quality control of trial, division of responsibilities in the trial, the cost of clinical trials undertaken by the sponsor and the treatment pr
16、inciple of injuries that may occur in the trial.Article 11 Clinical trials should be approved by ethics committee of clinical trial institutions. Medical devices listed in the directory of Class III medical device clinical trial shall also be approved by CFDA.Article 12 Before clinical trial, the sponsor s
