On March 12, 2021, the National Medical Products Administration (NMPA) issued the Announcement on Registration of Medical Device Master Files. It went into force immediately following its announcement.

The medical device master file registration system has been established in likeness to the Opinions of the State Council on Reforming the Review and Approval System for Pharmaceuticals and Medical Devices (No. [2015] 44, issued by the State Council). It aims to further improve the quality of medical device review and approval. This could establish a more scientific and efficient review and approval system, as well as protect the business secrets of various enterprises.

For MNCs and foreign investors of medical devices, the new registration requirement for the medical device master file will apply to nearly all market approvals (registration, modification, clinical trial etc.) for Type II and Type III imported medical devices in the Chinese market. It’s necessary to dig into the new documents and make adjustments to their existing master file registration system if needed.

BESTAO has translated the complete content of the Announcement and its annexes. The full text of these documents contains 2860 English words and 15 pages.

Please check the following link for further information, and Chinese version is also available on our regulatory library:  

English version:

http://www.bestao-consulting.com/translated/detail/566

Chinese version:

http://www.bestao-consulting.com/translated/detail/567

If you need more information, or any help on the topic, please contact:

assistant@bestao-consulting.com