To all concerned:
To further standardize the medical device registration and submission and technical review to provide a reference for charge of medical device products registration, the Center organized the preparation of the General Principles for Medical Device Registration Unit Division and now the Exposure Draft (attachment 1) is prepared, and is soliciting opinions from the general public. Please fill in the comments and suggestions on the Comments Feedback Form (Attachment 2) before May 7, 2017 and send it to the Center by E-mail.
Contact: Zhang Qi, Huang Yalan
Tel.: 010-86452952 86452958
1. The General Principles for Medical Device Registration Unit Division (Exposure Draft) (download)
2. Comments Feedback Form (download)
Center for Medical Device Evaluation, China Food and Drug Administration
April 20, 2017