To organize the formulation and supervise the implementation of standards, classification rules, nomenclature conventions and coding rules for medical devices; to formulate and implement the management system of medical devices registration; to undertake work related to medical devices registration and clinical trial approval; to formulate and supervise the implementation of medical devices GCP and technical guidance; to organize the inspection of R&D sites, and investigate and punish illegal acts.

1) Division of General Affairs

2) Division of Registration I

3) Division of Registration II

4) Division of Registration Research