歡迎來到南京友德邦醫(yī)療科技有限公司官網(wǎng)
According to the Circular of the General Office of the State Council of the Central Office of the Communist Party of China on "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices" (Office No. [2017] 42) and the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices (Decree No. 680 of the State Council of the People's Republic of China) Medical device clinical trial institutions shall be changed from qualification confirmation to record management. The former State Administration of Food and Drugs implemented the reform requirement of "release,and control and obey". In 2017, in conjunction with the former Health and Family Planning Commission, it issued "Conditions for Clinical Testing Institutions of Medical Devices and Measures for Record Management". It established the Record Management Information System for Clinical Testing Institutions of Medical Devices, which was put into operation simultaneously on January 1, 2018.
As of December 31, 2018, 676 institutions in 29 provinces, autonomous regions, municipalities directly under the Central Government and military hospitals have completed the record-keeping work of clinical trial medical devices institutions. A total of 1409 clinical specialties have been registered and 80 regulatory accounts have been issued. Among them, Guangdong, Jiangsu, Beijing, Shanghai and Zhejiang ranked among the top five clinical trial institutions in China, with 260 medical institutions completed the record. It is a continuous work for medical device clinical trial institutions to record, and eligible units can continue to record according to requirements and procedures. After one year's record-keeping work, the number of medical device clinical trial institutions is increasing, the division of institutions'specialties is detailed and accurate, the resources of medical device clinical trial are expanded, and the shortage of clinical trial institutions is solved.
