The Policy and Practice of Medical Device Emergency Approval at the Local Level under the Circumstance of COVID-19 Disease.
10.3969/j.issn.1671-7104.2021.04.017
- Author:
Shu YAN
1
;
Juan CHEN
1
;
Zhaolian OUYANG
1
Author Information
1. Institute of Medical Information & Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100020.
- Publication Type:Journal Article
- Keywords:
COVID-19;
emergency approval;
local level;
medical device
- MeSH:
COVID-19;
Device Approval;
Humans;
Policy;
SARS-CoV-2
- From:Chinese Journal of Medical Instrumentation
2021;45(4):429-433
- CountryChina
- Language:Chinese
-
Abstract:
This research analyzed Chinese emergency approval policies and practices of medical devices at the local level under the circumstance of COVID-19 disease. The legal basis and administrative system were clarified, the implementation and characteristics of emergency approval policies were investigated, the products information including total approved number, product type and license's validity period were counted. Advices as enhancing the standardization of emergency approval system, strengthening registration guidance and optimize information disclose and management were provided.
