Where can I apply for the registration certificate of medical device business enterprise?

Starting from 20 14, 10 and 1, the medical device business license or filing certificate must be declared online and approved on site.

You can click on the "Medical Device Production and Operation License Filing Information System" in the "Online Service" column on the homepage of the Food and Drug Administration.

After entering the landing page, there is a special operation manual and tutorial video download interface, which can be downloaded and used by the applicant enterprises.

When applying for licensing matters, it is necessary not only to complete the online declaration in the system, but also to submit paper materials to the corresponding examination and approval and filing departments before handling it.

The only difference between filing and licensing is that "basic introduction and functional description of computer information management system" can not be provided in the application materials.