"Shanghai Municipality Medical Device Production Enterprise Classification Supervision Implementation Rules" will be released to the public.

The Shanghai Municipal Drug Administration released the "Implementation Rules for Graded Supervision of Medical Device Manufacturing Enterprises in Shanghai" on the 25th. It proposes that the Municipal Drug Administration will classify enterprises into different supervision levels based on factors such as the category of medical devices approved for production by the enterprise, whether the products are included in the list of key supervised varieties, the operation status of the enterprise's production quality management system, and the supervision credit record, in accordance with the principles of "risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of responsibilities, and improvement of efficiency". It also specifies the corresponding supervision inspection forms, daily inspection frequencies, and coverage requirements. The supervision levels are divided into the following categories based on the approval for listing and production of medical devices by medical device manufacturing enterprises in this city, as well as the comprehensive risk credit rating of the enterprises.