Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation.
10.3969/j.issn.1671-7104.2022.04.017
- Author:
Xiaobin MA
1
;
Liang HONG
2
Author Information
1. Yunnan Institute of Medical Device Testing, Kunming, 650106.
2. School of Pharmaceutical Science & Yunnan Key Laboratory of Pharmacology for Natural Products, Kunming Medical University, Kunming, 650500.
- Publication Type:Journal Article
- Keywords:
feasibility;
medical device;
necessity;
supervision legislation
- MeSH:
Equipment and Supplies;
European Union;
Feasibility Studies;
Industry;
Medical Device Legislation;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2022;46(4):433-437
- CountryChina
- Language:Chinese
-
Abstract:
This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.
