Summary of the special inspection work of medical equipment by the Food and Drug Administration

First, the preparation stage

Under the high attention and correct leadership of the bureau leaders, according to the spirit and requirements of the archives of the Municipal Bureau, combined with the actual situation of the county, carefully study the contents of the archives, carefully deploy and make overall plans, and actively carry out special inspection activities.

Second, the implementation phase

There are 37 medical device management enterprises in our county, and there are no medical device manufacturers. During the inspection, the bureau strictly followed the inspection methods and inspection contents, focusing on the system construction of the operating enterprise, product purchase channels, purchase acceptance, consistency of ticket items, product traceability, changes in licensing items, and performance of personnel duties. During the inspection, it was found that some enterprises had not fully collected the legal qualification certificate of the supplier, the system was not perfect, and the purchase acceptance record was incomplete. The company has been required to seriously rectify the enterprise and conduct an enterprise without a license to operate medical devices. Filed a case.

Third, the summary stage

Through this special inspection, we further understood the operation of medical devices, standardized the order of medical devices, improved the regulatory files of enterprises, and obtained the collection and analysis of regulatory information, ensuring the safe and effective use of medical devices by the people.