医疗器械立法需求和立法空间研究

Research on the Legislative Demand and Space for Medical Devices

本文通过对我国医疗器械监管和产业发展历程的回顾与分析,结合新修订《医疗器械监督管理条例》面临的产业环境、社会环境和国际环境变化,从社会经济角度、民主法治角度、国际合作角度和科学监管角度等方面,研究和讨论了提升我国医疗器械管理的法律位阶的重要性、必要性和可行性,旨在进一步推动《医疗器械管理法》的相关立法准备,并以此“基本法”构建我国更为完善的医疗器械法治管理体系。

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.