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Medical device manufacturers will have credit files

Anhui food and Drug Administration learned that according to the newly revised "Anhui Province medical device manufacturing enterprise quality credit classification management measures", the drug supervision department will establish quality credit files for medical device manufacturing enterprises, which will be supervised by three levels of a, B and C. the daily supervision frequency of A-level enterprises will be reduced, and the B-level and C-level enterprises will be strengthened with preventive and prompt measures.
The main criteria for rating are the severity of the illegal activities, the size of subjective faults and the bad behavior records in daily supervision. A-level enterprises must meet six requirements at the same time: continuous normal production in this year, no record of bad behavior in daily supervision, effective operation of quality management system, qualified sampling conclusion of listed products for two consecutive years, active cooperation of enterprises with law enforcement agencies in supervision and inspection, and no violation of laws and regulations.
One of the ten cases of "being warned due to violation of laws and regulations" and "being ordered to rectify but not rectified in place" is rated as grade B, and those with one of eight situations such as "revoked approval number of medical device advertisement", "making up production record, sales record and production batch number" are rated as grade C. In addition to special inspection and report verification, the drug supervision department will announce to A-level enterprises to reduce the frequency of daily supervision and open up a green channel for handling affairs; for B-level and C-level enterprises, it will report to strengthen supervision, especially for C-level enterprises, strengthen the daily supervision and increase the frequency of supervision and sampling.
According to the provincial food and drug administration, there are more than 300 enterprises producing medical equipment, thermometers, band aids and medical masks. The implementation of credit classification supervision will promote the self-discipline and integrity of enterprises, promote the healthy development of the medical device industry, and ensure product safety.



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