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  • The general administration of the state has issued a notice on the quality of medical devices in the 18th issue of 2017
  • Release time: 2017-08-21 Clicks:1963 
  •  Published by the state food and drug supervision and administration bureau in 2017, 18 countries medical instrument quality announcement, for medical oxygen concentrator (medical oxygen generator), dental non-noble metal alloy casting (including the PFM alloy), three varieties of 155 (sets) of the product quality supervision and sampling of the announcement. Among them, the sampling inspection project does not meet the standard prescribed medical device products, involving 15 batches of 3 varieties of 9 medical device manufacturers. The sampling inspection program is not conforming to the standard medical device products for labeling, specification and other items, which involve 5 units of 5 medical device manufacturers. The sampling inspection program is fully compliant with the standard medical device products that involve the production of 54 medical device manufacturers 135 batches (Taiwan).
    The state food and drug administration has asked does not conform to the stipulations of the standard product enterprise local food and drug supervision and administration authority to investigate the relevant enterprises, and ask the relevant provincial food and drug supervision and administration department timely inform the public of the disposal.
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