Ma Xiaobin, Hong Liang
Yunnan Institute of Medical Device Testing, Kunming, 650106.
School of Pharmaceutical Science & Yunnan Key Laboratory of Pharmacology for Natural Products, Kunming Medical University, Kunming, 650500.
Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Jul 30;46(4):433-437. doi: 10.3969/j.issn.1671-7104.2022.04.017.
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 .
本文从加强依法行政、保护公众健康、完善医药法律体系以及促进医疗器械产业发展等角度，研究我国现行医疗器械监管立法的必要性。本研究分析总结了美国、欧盟、日本等国家和地区在医疗器械监管领域的立法经验和形式，目前我国开展医疗器械监管立法的条件已相当成熟，并针对立法提出了一些政策建议。
