The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder
10.12455/j.issn.1671-7104.240190
- VernacularTitle:上海市医疗器械注册人制度下委托生产注册体系核查现状与建议
- Author:
Minliang ZHOU
1
;
Ming MENG
;
Meikui TONG
Author Information
1. 上海市医疗器械化妆品审评核查中心,上海市,200020
- Keywords:
marketing authorization holder;
entrusted production;
registration quality system audit;
non-conformity
- From:
Chinese Journal of Medical Instrumentation
2024;48(6):683-688
- CountryChina
- Language:Chinese
-
Abstract:
This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders(MAH).Through sorting and analyzing typical non-conformities,highlighting the main responsibilities of registrants,and clarifying the obligations and rights of relevant parties.Meanwhile,it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.
