Main responsibilities

(1) Be responsible for the acceptance and technical review of registration application of domestic Class III medical device products and imported medical device products; be responsible for the filing of imported Class I medical device products.

(2) Participate in the drafting of relevant laws, regulations and normative documents related to the registration administration of medical devices. Organize the formulation and implementation of relevant technical reviews norms and technical guidelines for medical devices.

(3) Undertake the technical review of medical devices involved in emerging medical products such as regenerative medicine and tissue engineering.

(4) Coordinate the inspection work related to the evaluation of medical devices review.

(5) Carry out researches on the theories, technologies, development trends and legal issues related to medical device review.

(6) Be responsible for providing guidance and technical support for local departments in the technical review of medical devices.

(7) Organize relevant consulting services and academic exchange, and carry out international (regional) exchange and cooperation related to medical device review.

(8) Undertake other tasks assigned by NMPA.