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Food and drug administration: 24 batches of medical equipment unqualified list of equipment

Will dispose of nonconforming medical devices

  In order to strengthen the supervision and management of medical devices, the anhui provincial food and drug administration has conducted supervision and sampling tests on the quality of medical devices produced, operated and used by medical devices in administrative areas, according to a statement issued by the anhui provincial food and drug administration.

  After sampling and verification, a total of 24 batches (Taiwan) of 10 varieties of products do not meet the standards, including medical degreasing point gauze, customized denture, disposable infusion device with needle and warm medium and low frequency therapeutic equipment and other products. (list attached)

  The drug regulatory departments of each city (directly administered county) are dealing with the above-mentioned medical device products that do not conform to the standards in accordance with the regulations on the supervision and administration of medical devices and other relevant provisions.

  Sampling inspection for many years

  It is understood that in 2016, 2017 and 2018, anhui provincial food and drug administration conducted supervision and sampling tests on the quality of medical devices in medical device manufacturing, operating enterprises and users.

  According to anhui provincial food and drug administration, a total of 22 batches (Taiwan) of 10 varieties of products did not meet the standards after sampling and verification in 2018, including medical degreasing gauze sheets, specific electromagnetic spectrum therapeutic devices and breast therapeutic devices.

  In 2017, after sampling and verification, a total of 8 varieties and 10 batches (Taiwan) of products did not meet the standard provisions, including automatic arm electronic sphygmomanometer, digital display electronic thermometer, warm medium and low frequency therapeutic equipment and other products.

  In 2016, anhui provincial food and drug administration had two phases of quality supervision and sampling inspection. In the first phase, 12 batches of 10 varieties failed to meet the standard provisions, and in the second phase, nearly 200 devices were sampled. Finally, 10 batches (Taiwan) of 2 varieties of 7 medical device manufacturers failed to meet the standard provisions.