Ziyang special inspection high-risk medical equipment

Recently, the Ziyang Food and Drug Administration has carried out special inspections on high-risk medical devices for medical device operation and use units in the jurisdiction.

It is reported that the bureau has focused on the inspection of the inbound and outbound management of sterility and implantable high-risk products, the acceptance and acceptance records, the sales records, the traceability of computer management systems, personnel training, etc., and whether the medical devices that are sold or not have undergone Whether the license is filed, whether the product registration certificate or filing certificate is obtained, whether the purchase and sale channels are legal, and whether the medical equipment used in the existing business is expired.

Up to now, a total of 43 medical device operating units have been inspected. For those units that have found that they do not meet the requirements, the law enforcement personnel have clarified the corrective measures and time limits. In the next step, Ziyang Food and Drug Administration will continue to inspect other key enterprises, conduct in-depth investigations on potential risks of medical devices, and promote legal and compliant production and operation of medical device enterprises.