The state food and drug administration has issued a special review procedure for innovative medical

Sina pharmaceutical learned today (nov 5) that the state drug administration has issued an announcement on the special review procedures for innovative medical devices (no. 83, 2018).


It is understood that the newly revised "special review procedure for innovative medical devices" has improved the application situation, detailed application process, improved the effectiveness of the innovation review, improved the review mode and notification form, and made clear the priority of changing the licensing items of innovative medical devices. The program setting is more scientific and effective, which is conducive to improving the efficiency of the examination of innovative medical devices and playing a positive role in encouraging the innovation and development of the medical device industry.


For the implementation of the general office of the central committee of the communist party of China, the general office of the state council "about deepening the review of the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation" word [2017] no. 42 (hall), encourage the innovation of medical equipment, promote the promotion and application of new technology of medical equipment, promote the development of high quality medical equipment industry, the state drug administration organization revised innovation medical instrument special review procedures, are hereby issued, and effective as of December 1, 2018. The "special examination and approval procedures for innovative medical devices (trial)" issued by the former state food and drug administration (fda) (food and drug control [2014] no.13) shall be abolished simultaneously.