Discussion of Enlightenment from the Reorganization of CDRH Regulatory for Medical Device.
10.3969/j.issn.1671-7104.2020.02.012
- Author:
Hui SHANG
1
;
Shiqing ZHANG
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100089.
- Publication Type:Journal Article
- Keywords:
Center for Devices and Radiological Health (CDRH);
reorganization;
total product lifecycle of medical device
- MeSH:
Device Approval;
Marketing;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2020;44(2):154-157
- CountryChina
- Language:Chinese
-
Abstract:
This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.
