Analysis and Suggestions on Status Quo of Commissioned Production under Medical Device Marketing Authorization Holder System in China.
10.3969/j.issn.1671-7104.2022.02.017
- Author:
Bingbing XING
1
;
Tianping HE
2
;
Dawei ZHANG
2
;
Yi LIANG
1
Author Information
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 211198.
2. Institute of Jiangsu Medical Products Administration, Nanjing, 210008.
- Publication Type:Journal Article
- Keywords:
commissioned production;
medical device marketing authorization holder;
quality;
risk
- MeSH:
China;
Marketing
- From:
Chinese Journal of Medical Instrumentation
2022;46(2):195-199
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:Sort out and analyze the current status and existing problems of the pilot work of the medical device marketing authorization holder system to provide reference opinions for the full implementation of the medical device marketing authorization holder system.
METHODS:Use literature analysis, comparative analysis and field research to comprehensively analyze the status, advantages and risks of commissioned production under the medical device marketing authorization holder system.
RESULTS:The commissioned production under the medical device marketing authorization holder system brings dividends and also brings risks.
CONCLUSIONS:We should consider improving the medical device marketing authorization holder system from marketing authorization holder, the entrusted manufacturer, and the regulatory authority, and strengthen the quality supervision of the entrusted production of products.
