Analysis of filing review of Class I medical devices in some city of Anhui Province from 2021 to 2022
10.19745/j.1003-8868.2023235
- VernacularTitle:安徽省某市2021-2022年第一类医疗器械备案审查情况分析
- Author:
Kun TONG
1
;
Dian ZHOU
;
Mu-Yao ZHENG
Author Information
1. 安徽医科大学卫生管理学院,合肥 230032
- Keywords:
Anhui Province;
Class I medical device;
filing application;
filing review;
filer
- From:
Chinese Medical Equipment Journal
2023;44(11):90-94
- CountryChina
- Language:Chinese
-
Abstract:
China's Class 1 medical devices whose applications for filing were accepted in Anhui Province drug licensing system from January 2021 to December 2022 in some city of Anhui Province were used as the study object.The problems were analyzed in filing application,review and filing materials.It's suggested that the filer pay attention to the definition of medical devices,specifications for compiling filing materials,rigor of filing materials and whole-process quality management of medical device filing.References were provided for Class I medical device filer to standardize filing application materials and regulatory authorities to strengthen in-process and ex-post supervision of Class I medical device filing.[Chinese Medical Equipment Journal,2023,44(11):90-94]
