In order to strengthen cross-regional entrustment supervision of medical device registrants, strengthen the quality management responsibility of medical device registrants in the whole life cycle, and guide local drug regulatory departments to strengthen coordination and cooperation in supervision, recently, The State Food and Drug Administration issued the Opinions on Strengthening the Collaborative Supervision of Trans-regional Entrusted Production of Medical Devices (CFDA Comprehensive Equipment Management (2022) No. 21). The Opinions contain three main contents:
First, clear requirements and improve mechanisms. Local drug regulatory departments are required to strengthen cross-regional regulatory coordination and cooperation on the basis of fulfilling their local regulatory responsibilities, so as to form a regulatory working mechanism with clear responsibilities, unimpeded information, orderly connection and strong coordination, so as to promote the high-quality development of the medical device industry and ensure the safety and effeciency of the devices used by the people.
Second, a clear division of labor, leaving no dead spots. Further clear registrant for the record and the local drug regulatory department entrusted production enterprise quality system verification, production process in the medical device registration, adverse event monitoring of sampling observation of quality supervision and inspection, supervision links such as the responsibility of the division of labor, improve the various links across the regional regulatory mechanism, to ensure that for the whole life cycle of medical apparatus and instruments, the whole chain supervision 'seamless' 'no dead Angle'.
Third, refine the provisions and standardize measures. In the newly revised 'medical devices supervision and administration of production method' relevant provision, on the basis of 'opinion' detailing the cross-regional the implementation of the supervision and inspection, the application of the joint inspection, the entrusted inspection situation, guide the local drug regulatory departments of registrant record filing system under the new situation of the full implementation of the supervision work to different regions, clear regulatory responsibilities, Eliminate regulatory blind spots.
The Opinions implement the 'four strictest' regulatory requirements, and make specific requirements for local drug regulatory authorities to strengthen regulatory coordination, strengthen regulatory information connectivity, and seriously investigate and punish violations of laws and regulations, so as to further promote local authorities to improve the collaborative regulatory system and form regulatory synergy.
