Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment.
10.3969/j.issn.1671-7104.2020.03.012
- Author:
Qingfeng LUO
1
;
Jiaxin TIAN
1
;
Yongqing WANG
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
drug-device combinations;
enlightenment;
supervision
- MeSH:
European Union;
Marketing;
United States
- From:
Chinese Journal of Medical Instrumentation
2020;44(3):246-248
- CountryChina
- Language:Chinese
-
Abstract:
This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.
