Aseptic and implantable medical devices are high-risk medical devices, and product quality is directly related to public health and life safety. In order to ensure the safety of public equipment, the Liaoning Provincial Bureau has recently formulated the Work Plan for the Supervision and Inspection of sterile and implantable Medical Devices in the province, and organized a six-month special supervision and inspection in the province, focusing on cracking down on illegal activities in the production, operation and use of sterile and implantable medical devices.

First, clear inspection objectives. To inspect irregularities such as incomplete production, acceptance and use records in secondary and tertiary hospitals and implanting medical device production and operation enterprises in the province, urge and rectify the units and enterprises with problems, and guide enterprises to establish, improve and effectively implement the medical device procurement and acceptance system. At the same time, we will severely crack down on illegal activities such as unlicensed operation and use of unregistered medical devices, and strive to achieve "rectification of a class of products, regulation of a behavior, and purification of an industry."

Second, highlight key content. In the production process, the focus is on checking whether the clean room (area) control meets the requirements, and whether the production equipment and inspection equipment match the products and scale produced. In the business link, the focus is on checking whether it is engaged in operating (online sales) medical devices without permission (for the record), whether it is operating (online sales) medical devices that have not obtained registration certificates or for the record. In the use link, the focus is on checking whether the purchase, use of medical devices that are not registered or filed according to law, no qualification documents, and expired, invalid, and eliminated.

Third, crack down on illegal activities. Hold on to the clues that you find, and get to the bottom of it. Resolutely file and investigate suspected violations, resolutely suspend operations for rectification in accordance with the law, have affected product quality and safety, and resolutely and promptly transfer illegal problems in line with the transfer situation. Through administrative punishment, notice exposure, execution convergence, joint punishment and other measures, severely crack down on violations in the field of medical devices.