In order to strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the State Food and Drug Administration recently issued the "Medical Device Quality Announcement" (the 12th issue of 2017, the total 30th issue).。The "Medical device quality Announcement" in the sample test project does not meet the standard provisions of the medical device products, involving 2 batches (units) of a medical device manufacturing enterprise in our city, our bureau has punished the unit。