What is the process of medical device registration?

It depends on what class your product is, the current regulations Class II and Class III are required to register, a class only need to record.

The total process can be referred to as follows:

Determine the technical requirements of the product - registration test - do clinical trials - obtain clinical reports -Compile a full set of registration information -Submit to the Drug Administration for review -Factory site system audit -Technical Review - make corrections - administrative approval - obtain registration approval

After obtaining the product registration certificate and then submit the application information to the Drug Administration to apply for a factory production license.

For products that are exempted from clinical trials, the intermediate clinical trials related links can be eliminated. Whether or not they are exempt from clinical trials needs to be viewed in the context of the current medical device catalog and professional judgment.

Based on so many years of experience, the process of medical device registration is still very complex, in which the passive products involve the verification of sterility, which is a great test of the professionalism and experience of the technical and regulatory personnel. The main difficulty of active products lies in the rectification of the testing process. Of course, whether active or passive products, involving literature collection, risk evaluation, system set up audit and so on.