Class II medical device company has a "medical device manufacturer quality system assessment report", but no ISO9001 certificate, can continue to produce and sell?

I. To produce and sell products, you need to obtain the "Medical Device Manufacturing License" and "Medical Device Product Registration Certificate". (If you sell your own products. (You do not need a "medical device license") on it. You sell imported products is definitely need "Medical Device License".

Two, ISO9001 certification, is not a mandatory certification of medical device companies. Does not affect the production and sales.

Three, medical device manufacturing companies, through the ISO13485 certification is more convincing.

Four, "medical device manufacturers quality system assessment" has a large part of the ISO13485 basis to examine.

Fifth, ISO certification can standardize the company's quality system. At the same time for marketing, can be used as a qualification, more convincing to customers.

Sixth, "Medical Device Manufacturer Quality System Report" is in the product registration certificate before you get.

Meticulous, if you still do not understand, you can ask me again.