The National Medical Products Administration (NMPA) has released a set of Guiding Opinions on “Medical Device Manufacturing and Operation Grading Administration,” aimed at strengthening supervision of medical device manufacturing and operation under the medical device marketing authorization holder (MAH) system. The guidelines will take effect on January 1, 2023.
Regulatory Framework
The guidelines require that medical device production and distribution companies be supervised on four regulatory levels based on risk, with corresponding regulatory measures implemented. For enterprises with a good regulatory credit status over a long period, the regulatory level can be lowered as appropriate. For cross-regional entrusted production of medical device registrants, entrusted production enterprises that only carry out entrusted production, and distributors that add warehouses in other jurisdictions, the supervision level should be increased appropriately. Medical device manufacturers and distributors should be subject to unannounced inspections.
Key Regulated Varieties and Dynamic Adjustments
The NMPA has formulated a list of key regulated varieties based on the degree of risk of medical device products and their operations. The document requires municipal medical products administrations to supplement the list according to local conditions and make dynamic adjustments. It also calls for medical products administrations at all levels to strengthen coordination, establish cross-regional and cross-level collaborative supervision mechanisms, enhance regulatory capacity, enrich regulatory resources, and improve the quality supervision of medical devices throughout their lifecycle.-Fineline Info & Tech
