This article reviews and analyzes the regulatory and industrial development process of medical devices in China,considering the evolving industrial,social,and international environment reflected in the recent revision of the Regulations for the Supervision and Administration of Medical Devices.From the perspectives of socio-economic,democratic rule-of-law,international cooperation,and scientific supervision,the article explores the importance,necessity,and feasibility of elevating the legal status of medical device supervision and administration in China.The aim is to further promote the legislative groundwork for the Medical Device Administration Law,using it as a foundational law to build a more comprehensive legal management system for medical devices in China.
关键词
医疗器械/立法/研究和创新/中国特色/法治管理体系
Key words
medical devices/legislation/research and innovation/Chinese characteristics/rule-of-law management system
维普
万方数据