The National Medical Products Administration (NMPA) is currently seeking public feedback on the “Opinions on Further Strengthening the Supervision of Production Commissioned by Medical Device Registrants (draft proposal)” until August 20, 2023. The initiative aims to fully implement the primary responsibility of medical device registrants for quality and safety, prevent and control risks in contract manufacturing, and enhance the supervision of medical device production commissioned by registrants.<\/p>\n\n\n\n
Clarification of Registrant Responsibilities<\/strong> Standardization of Commissioned Production Registration Certificates<\/strong>
The draft proposal clarifies that registrants must establish a quality management system covering the entire lifecycle of medical devices. They should establish and improve a management organization suitable for the product characteristics and enterprise size, allocate sufficient management personnel, and fully perform responsibilities related to product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring, and product recall. For implantable medical devices, registrants are encouraged to manufacture them themselves, and products listed in the “Catalogue of Prohibited Commissioned Production of Medical Devices” must not be contracted out.<\/p>\n\n\n\n
For medical devices registered under a contract manufacturing arrangement or for registrants whose registration certificate renewal involves contract production, the registration approval department must record the contract production address and indicate “(commissioned production)” in the production address column of the medical device registration certificate. The name of the contract production enterprise and the Unified Social Credit Identifier must be noted in the remarks column. If the required information is not marked, re-labeling must be completed before December 31, 2023.<\/p>\n\n\n\n