1, you must be a production-oriented enterprises (see business license)
2, in the Pharmacovigilance did 1 class medical device manufacturer registration
3, business license with 1 class medical device production business scope
4, write enterprise standards, to the Provincial Bureau of the review
5, self-inspection self-testing or commissioned testing
6, enterprise standard, test The results, together with the license, manufacturer registration form, etc. to the local municipal Drug Administration.
7. Get a license (from the submission of the standard to get a license about 3 months)
Roughly, the specific details, you can go to the local Drug Administration for free advice