[Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation(2022)
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 .
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Key words
feasibility,medical device,necessity,supervision legislation
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