Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process.
10.3969/j.issn.1671-7104.2020.04.012
- Author:
Wengchi LAN
1
;
Lei SUN
1
;
Rui FAN
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
medical device;
review process;
risk analysis
- MeSH:
China;
Device Approval;
Quality Control;
Risk Assessment
- From:
Chinese Journal of Medical Instrumentation
2020;44(4):334-337
- CountryChina
- Language:Chinese
-
Abstract:
In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.
