Notice on flight inspection of medical devices

In order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical devices, according to the regulations on the supervision and management of medical devices, the measures for the supervision and management of the production of medical devices, the measures for the flight inspection of medical devices, the specifications for the quality management of the production of medical devices and the relevant appendix, and the notice of the State Food and Drug Administration on printing and distributing the specifications for the quality management of the production of medical devices on-site inspection According to the requirements of the notice on the four guiding principles including the guiding principles (sfyjxj [2015] No. 218), the verification center organized and carried out the flight inspection of medical device manufacturers in November 2020 in accordance with the medical device inspection work deployment of the State Drug Administration in 2020, and developed Shenzhen yahuilong Biotechnology Co., Ltd The general items of these enterprises did not meet the requirements of "medical device production quality management specification" and relevant appendix. See the attached table for details.

In view of the problems found in the inspection that the general items do not meet the requirements, the drug administration of the relevant provinces, autonomous regions and municipalities directly under the central government shall urge the enterprises to rectify within a time limit, require the enterprises to assess the product safety risks, and recall the relevant products in accordance with the administrative measures for medical device recall if there are safety risks. After the enterprise completes the rectification, the relevant provincial drug administration shall timely organize the confirmation of the rectification, and submit the confirmation results to the food and drug audit and inspection center of the State Drug Administration.