Division of Product Registration:
Functions:
1.Responsible for inspection, instruction and examination of the national registration processes;
2.Responsible for formulating and amending statutes of medical device registration;
3.Responsible for administrative examination and approving processes in registration of Class III medical devices manufactured by enterprises within our national borders;
4.Responsible for administrative examination and approving processes in registration of imported medical devices;
5.Responsible for examination and approving clinical use of medical device products;
6.Responsible for export certification of medical device products;
7.Responsible for organization and arrangement in examination of production quality system for overseas medical device products;
8.Responsible for liaison with foreign examination and approving institutions of medical device products and with international institutions;
9.Responsible for filing on record for regional registration of Class I and II medical device products manufactured within our national borders;
10.Responsible for formulating and issuing the lists of scrapped and obsolete medical device products;
11.Responsible for issuing public notice about registration of medical device products;
12.Responsible for selecting and inviting evaluation specialists for medical devices, and management of medical device experts database;
13.Responsible for the works of Import and Export Office of Electromechanical Products of State Food and Drug Administration.

Office: Room 1102, Office Building of State Food and Drug Administration

Person in Charge: Chang Yongheng