What are the procedures for foreign companies to apply for the registration certificate of imported medical devices

Prerequisite: overseas manufacturers to obtain medical device listing qualification in the country of origin, each region is different, the form of listing certificate is different.

Steps: 1 samples or prototypes to be sent for testing, to be recognized by the State Drug Administration testing institute. 2 to find overseas manufacturers to obtain clinical data (if the products in the exempted clinical directory can be without clinical trials, if the data is not enough need to carry out a very complex clinical trials). 3 to prepare imported documents for registration. 4 to send the registration documents to notarize foreign countries in advance of the Chinese registration documents translated into a foreign language to facilitate the notarization. 5 to go to the The FDA to make paper declaration and online electronic declaration. 6 according to the FDA's modification of the views of the document modification. 7 to obtain a license.