Inspection and sampling monitoring are the three most important means of finding problems and capturing risks. The Provincial Food and Drug Administration strictly controls product quality, improves the method of inspection and sampling monitoring, explores the implementation of "blind sampling and blind inspection", strengthens "secret visits and secret investigations", strengthens "linkage joint offices", severely cracks down on all kinds of violations of laws and regulations, timely follows up and deals with hidden problems found, implements closed-loop management, ensures that problems are rectified in place, and guards the safety of public use of medicinal equipment and cosmetics.
Recently, the fifth branch of the Provincial Food and Drug Administration organized a special inspection activity for the production of plastered medical devices.
In this inspection, the focus is on the medical cold compress production enterprises with large brands in the jurisdiction to check whether the "mechanical plaster" produced by them meets the definition of medical devices, whether the labels and instructions of the products meet the specifications, and whether there is improper behavior of publicizing the efficacy of the products with the mechanical brand. At the same time, the plaster equipment manufacturers in the jurisdiction carry out drag-net inspections to see whether the relevant enterprises organize production in accordance with the technical requirements of registered or filed products, and whether a quality management system has been established and maintained in accordance with regulations. Strengthen the sampling inspection of related products, carry out sampling inspection of plastered medical devices, and urge enterprises to fulfill their main responsibility obligations and do a good job in monitoring adverse events.
The fifth branch of the Provincial Food and Drug Administration strengthens communication and cooperation with the market supervision department and the public security department, timely grasps the clues of relevant illegal acts, and if it is found that the enterprise violates the relevant laws and regulations of medical devices, it shall be seriously investigated and dealt with in accordance with the law; if it violates the laws and regulations of trademarks, advertisements and other laws, it shall be promptly transferred to the market supervision department for investigation and handling; if it is suspected of committing a crime, it shall be promptly transferred to the public security organ. Up to now, 6 plaster medical device manufacturers have been inspected, and the problems found in the inspection have been urged to rectify.