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Twenty-five medical device companies' medical masks product sampling failure

  • Author:Dreamy F
  • Source:www.china-disposable.com
  • Release on :2016-05-13
Recently, the China Food and Drug Administration of Medical Devices released the latest national quality bulletin.Notice that, in terms of quality supervision and sampling of medical protective masks, gowns and other six varieties of 313 batches (Taiwan) products, there are six varieties of 25 medical device manufacturers of 28 batches (Taiwan) products do not meet the standard requirements.The products does not meet the standard requirements for medical devices, including high-potential therapeutic equipment, medical protective masks, surgical gowns, nerve and muscle stimulator, a one-time use of portable infusion pump.

Administration Food and Drug Administration requirements for sample testing found the product does not meet the standard requirements, the enterprise is located food and drug regulatory departments should investigate and deal with related businesses, constituting a crime shall be investigated for criminal liability.Related medical equipment manufacturing enterprises to cope not meet the standard requirements of the product and project risk assessment to determine the level of recall, voluntarily recalled by the enterprise and public recall information based on the severity of the medical device defects.Business location food and drug regulatory authorities to deal with companies recall supervise, unorganized recall should be ordered to recall; is found not to meet the standard requirements of medical device products cause harm to humans or there is evidence of possible harm to human health, it can be taken to suspend production, emergency measures to control the import, operation and use.

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