论2021年《医疗器械监督管理条例》的修订与影响

介绍了《医疗器械监督管理条例》(以下简称《条例》)的法律属性与地位,详细分析了2021年版《条例》修订确立的风险管理、全程管控、科学监管、社会共治以及严格责任等监管原则,指出2021年版《条例》在将医疗器械注册人制度确立为医疗器械行业基本制度的同时规定了多项旨在满足临床急需的管理制度。阐述了2021年版《条例》的修订对产业创新发展和产业整体安全产生的深远影响,对医疗器械法规研究以及行业产业发展具有重要的意义。

Revision and impact of"Regulations on supervision and administration of medical devices"2021

The legal attributes and status of the"Regulations on supervision and administration of medical devices"were introduced,and the regulatory principles of risk management,whole-course control,scientific supervision,social governance and strict liability established in the 2021 edition of the Regulations were analyzed in detail.It's pointed out that the 2021 edition of the Regulations established the medical device registrar system as the basic system of the medical device industry while providing for a number of management systems designed to meet urgent clinical needs.The 2021 edition of the Regulations was described as having a profound impact on the innovative development and the overall safety of the industry,and was of great significance to the study of medical device regulations and the development of the industry.