Solution to Unify the Review of Domestic Second Class Medical Device.
10.3969/j.issn.1671-7104.2019.01.012
- Author:
Weiming QI
1
;
Wenwu ZHU
1
Author Information
1. Evaluation Center of Medical Device in Zhejiang Province, Hangzhou, 311121.
- Publication Type:Journal Article
- Keywords:
classification;
data sharing;
quality management system;
review criteria;
unified evaluation
- MeSH:
China;
Device Approval;
Technology
- From:
Chinese Journal of Medical Instrumentation
2019;43(1):48-50
- CountryChina
- Language:Chinese
-
Abstract:
In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.
