The Food and Drug Administration released the third national medical device quality announcement in 2016

Recently, the State Food and Drug Administration announced the third national medical device quality announcement in 2016, and announced the quality supervision and inspection of eight varieties of 299 batches (tableware) such as medical surgical masks, medical electronic thermometers and metal bone screws. Among them, the medical device products that are not in conformity with the standard are involved in the test, and the eight batches of the eight medical device manufacturers are 32 batches (sets); the items to be tested are medical device products that do not meet the standard requirements such as labeling labels and instructions. There are 3 varieties and 5 batches (sets) of 4 medical device manufacturers; all the sampling products are in compliance with the standard. The medical device products involve 263 batches (sets) of 6 varieties of 142 medical device manufacturers.

At present, the State Food and Drug Administration has required the food and drug supervision and administration department of the place where the product enterprise does not meet the standards to investigate and deal with relevant enterprises. And the relevant provincial food and drug supervision and administration departments are required to promptly disclose the disposal situation to the public.

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