How to run a company for medical equipment commissioned processing?

Currently the requirements of the Drug Administration is in the medical device industry does not allow OEM cooperation way, you if you want to do their own brand can only have their own production capacity, of course, at the beginning of your production scale can be very small, do not have to be very large, but the relevant production licenses and certificates of registration of medical devices and so on need to be in their own name to go to the process, and must meet the requirements of the appropriate production system.

The medical device commissioning process mentioned in the regulations, to my personal understanding is for their own production capacity, but their own production capacity does not meet the sales requirements, can be commissioned production. The premise of the commissioned production is that the first you have to have a production license and certificate of registration of medical devices, the second your own production capacity can not meet the sales requirements of their own companies, the third for the commissioned party must also have the production capacity and production license, the scope of the production license must cover the products you want to commission.