On September 9, the State Food and Drug Administration issued the “Guiding Opinions on Strengthening the Classified Supervision of Medical Device Production and Operations” (hereinafter referred to as the “Opinions”) to guide local drug regulatory authorities to better carry out supervision of medical device production and operation under the medical device registrant system. The “Opinions” will come into effect on January 1, 2023.
The “Guiding Opinions” require the provincial drug regulatory authorities and the departments responsible for drug supervision and administration at the districted municipal level to combine industrial development and regulatory realities, give full play to the effectiveness of regulatory resources, formulate detailed requirements for production and operation hierarchical supervision that are consistent with the actual conditions of the region, and organize and implement hierarchical supervision of medical device production and operation in accordance with the principles of “risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of responsibilities, and improvement of efficiency.”
The “Guiding Opinions” put forward the principles and inspection requirements for the classification of supervision levels for medical device production and operation enterprises. The drug regulatory department can divide medical device enterprises into four supervision levels according to risks, and implement corresponding supervision measures for enterprises at different supervision levels. For enterprises with good regulatory credit status for a long time, the supervision level can be lowered as appropriate; for medical device registrants with cross-regional commissioned production, entrusted production enterprises that only engage in entrusted production, and operating enterprises with additional warehouses in other places, the supervision level should be raised as appropriate. Supervision and inspection of medical device manufacturers shall be carried out without prior notification, and unannounced supervision and inspection of operating enterprises shall be carried out.
The “Guiding Opinions” require drug regulatory authorities at all levels to further strengthen overall coordination and establish and improve cross-regional and cross-level collaborative supervision mechanisms; continue to strengthen problem handling, and handle problems discovered during inspections in a timely manner in strict accordance with laws and regulations; continue to strengthen regulatory capacity building, enrich regulatory resources, effectively conduct quality supervision throughout the life cycle of medical devices, and ensure the safety of people’s use of medical devices.
Original text: The State Food and Drug Administration issued guidance on strengthening the hierarchical supervision of medical device production and operation