If only MAH were to be spoken on September 14, many of them were still ignorant.
But to put it bluntly, this policy will give individuals a registration certificate for medical devices, and the old era of "factory can have" is over.
And with the "certificate factory separation", the era of the supremacy of medical devices in the industrial and commercial relations with the possession of the registration certificate will be concluded.
It is reported, on September 13, eat food and drug administration of Shanghai and pudong new area government signed a contract, take the lead in the pilot medical apparatus and instruments registrant system, all eligible medical instrument registrant (including enterprises and individuals) can apply for medical device registration certificate separately, and then through commissioned production, so as to realize "there is no factory can have medical equipment ownership" dream, medical device registration certificate and production enterprise can be separated.
Released early this year, the CFDA has relevant policy draft said, to summarize the drug marketing authorisation holder pilot experience, combined with the pharmaceutical administration law of the revision, the marketing authorisation holder system in the national drug and medical device license (registration) of common practice.
The medical device registrant system is also an internationally accepted rule. This can let the production of the people specialized in the production, let the understanding market, understand the terminal person to do the product development, to the industry undoubtedly has brought the great positive.
In this context, you can imagine, a batch of a medical device distribution enterprise market channels, will be most likely to apply for the registration certificate of medical equipment, has a group of registration certificate, then find production enterprise OEM production, or do yourself.
And in the past, the future do sales again big, also need not worry about the upstream manufacturers' necks, or even withdraw the agency hegemonic behaviour, because the product registration certificate in his own hands, agents, bag business is possible is the best in the future, the hegemony of medical device manufacturers era will be over.
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