Main responsibilities

(1) Assist the Center for Medical Device Evaluation of NMPA in pre- and in-process communication and guidance, as well as relevant inspections for medical device review in the Yangtze River Delta (YRD) region.

(2) Assist in the technical review of registration application of domestic Class III medical device products and imported medical device products in the YRD region under the administration of the Center for Medical Device Evaluation of NMPA.

(3) Assist in the supervision inspection of clinical trials of medical devices in the YRD region under the administration of the Center for Food and Drug Inspection of NMPA (National Center for Vaccine Inspection).

(4) Participate in the drafting of relevant laws, regulations and normative documents related to the registration administration of medical devices; participate in the formulation of relevant technical review norms, technical guidelines, inspection system specifications and technical documents for medical devices and organize the implementation.

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

(6) Carry out relevant consulting services, academic exchanges, and international (regional) exchanges and cooperation related to medical device review and inspection.

(7) Undertake other tasks assigned by NMPA, and other technical work assigned by the Center for Medical Device Evaluation of NMPA, and the Center for Food and Drug Inspection of NMPA (National Center for Vaccine Inspection).