医疗器械网络销售的监管现状与对策探讨

Supervision of Online Distribution of Medical Devices:Status quo and Suggestions

新修订《医疗器械监督管理条例》自2021年6月1日正式生效,社会关注的热点医疗器械网络销售首次写入条款。本文通过介绍医疗器械网络经营现状及发展需求,提出了从完善法制、激发企业主体责任、加强监管力度、提升社会认知等方面构建全方位监管体系的建议,以保障人民群众用械安全、产业健康发展。

The newly revised Regulations on the Supervision and Administration of Medical Devices came into effect on June 1,2021,which,for the first time,covered the much concerned topic of medical device online distribution.To meet the regulatory challenges posed by the current situation and development trend of medical device online distribution,this article proposes to build a comprehensive supervision system by improving the legal system,urging enterprises to take primary responsibilities,strengthening regulation and raising social awareness,so as to promote safe use of medical devices and the healthy development of the industry.