Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US.
10.3969/j.issn.1671-7104.2020.06.016
- Author:
Yifei ZHAO
1
;
Fang DONG
1
;
Yan ZHAO
1
;
Lijia ZHENG
1
Author Information
1. Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022.
- Publication Type:Journal Article
- Keywords:
inspection;
medical device reporting;
post market surveillance
- MeSH:
China;
Equipment and Supplies/standards*;
Product Surveillance, Postmarketing
- From:
Chinese Journal of Medical Instrumentation
2020;44(6):545-548
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China.
METHODS:The MDR system and the related inspection system in the US were systematically analyzed.
RESULTS:The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system.
CONCLUSIONS:By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.
