In order to implement the Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices (Office Letter [2017] No. 42) and the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680 of the People's Republic of China) issued by the General Office of the Communist Party of China Central Committee and the General Office of the State Council, implement the spirit of streamlining administration, delegating powers, combining administration, and optimizing services of the State Council, and further promote the reform of the evaluation and approval system, the State Administration for Food and Drug Regulation, in conjunction with the National Health and Family Planning Commission, jointly issued the Measures for the Conditions and Filing Management of Clinical Trial Institutions for Medical Devices (hereinafter referred to as the "Filing Measures"), which will come into effect on January.

The Filing Measures are divided into five chapters, including General Provisions, Filing Conditions, Filing Procedures, Supervision and Management, and Supplementary Provisions, totaling 20 articles. Clarified the purpose, definition, and scope of application for the registration of clinical trial institutions for medical devices. It stipulates the conditions that clinical trial institutions should possess, including the qualification of a second level A or higher institution, the establishment of a specialized clinical trial management department, personnel, management system, and other related requirements. The filing procedures have been clarified, and the Food and Drug Administration has organized the establishment of a medical device clinical trial institution filing management information system, which is used for clinical trial institution registration, filing management, and for all parties to query. It has been clarified that food and drug regulatory departments at or above the provincial level and health and family planning administrative departments are responsible for organizing supervision, management, and information communication of clinical trial institutions according to their respective responsibilities.

After the implementation of the "Filing Measures", medical device clinical trial institutions can log in to the website of the State Administration of Food and Drug Administration (website) http://www.cfda.gov.cn ）Record in the Medical Device Clinical Trial Institution Record Management Information System. Relevant units and individuals can query the registration information of medical device clinical trial institutions through the "Medical Device Clinical Trial Institution Registration Management Information System".

The promulgation and implementation of the "Filing Measures" will encourage more medical institutions that meet the evaluation criteria to participate in clinical trials of medical devices, which is conducive to releasing clinical resources, expanding the number of clinical trial institutions, and better meeting the needs of clinical trials of medical devices. It is of great significance to encourage innovation in medical device products and promote the healthy development of the medical device industry.