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.
Clarification of Registrant Responsibilities
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.
Standardization of Commissioned Production Registration Certificates
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.
Improvement of the Exit Mechanism for Registrants
If a registrant ceases medical device production and business activities, they must apply for the cancellation of the medical device registration certificate and production license promptly. They must also continue to perform responsibilities related to adverse event monitoring, product recall, and liability compensation to ensure the safety and efficacy of the listed products.
Innovation in Regulatory Methods
The proposal encourages drug regulatory authorities to explore synchronous supervision and inspection at both the registrant and contract production enterprise sites. This includes remote network connection to the inspection site, timely communication of inspection information, and unified inspection standards. Drug regulatory departments at all levels should improve cross-regional collaborative supervision mechanisms to enhance inspection and regulatory efficiency. The drug regulatory department where the registrant is located must draft a cross-regional contract production inspection plan before March 31 of each year and notify the drug regulatory department where the contract production enterprise is located.-Fineline Info & Tech
