Announcement on the release of special review procedures for innovative medical devices

In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" of the General Office of the Communist Party of China and the General Office of the State Council (Huang Zi [2017] No. 42), encourage medical device R&D and innovation and promote the promotion of new medical device technologies And application, and promote the high-quality development of the medical device industry. The State Drug Administration has revised the "Special Review Procedures for Innovative Medical Devices", which is now released and will be implemented as of December 1, 2018. The "Special Examination and Approval Procedures for Innovative Medical Devices (Trial)" (Food and Drug Supervision and Administration [2014] No. 13) issued by the former State Food and Drug Administration shall be abolished at the same time.

　　 Special announcement.

　　 Annex: Innovative Medical Device Special Examination Procedure