In order to implement the "Medical Device Supervision and Management Ordinance" (State Council Decree No. 650) and the "Opinion of the State Council on the reform of drug and medical device review and approval system" (Guo Fa [2015] 44), and to further promote the preparation and technical review of the declaration of innovative medical devices prescribed in the "Special Approval Procedures for Innovative Medical Devices" (No. 13 [2014] of the Food and Drug Administration), CFDA has formulated the Guideline for the Preparation of the Application Form for Special Examination and Approval of Innovative Medical Devices, which is hereby promulgated.

Notice is given hereby.

CFDA

14th Dec,2016