新修订的《医疗器械监督管理条例》已于2021年6月1日实施,该条例继续保留了医疗器械经营监管的基本制度性规定。本文基于对北京、上海、湖南、陕西、甘肃、河南等部分省市药监局在医疗器械经营环节所开展的监管工作的调研,对一些制约市场主体发展、可以通过主体责任落实解决的问题及域外先进管理经验进行了分析,梳理归纳了近年来国家药监局和地方监管部门出台的一系列加强医疗器械经营监管的工作制度、机制,以及其对加强医疗器械监管、规范医疗器械经营秩序起到的重要作用;也针对监管实践中发现的薄弱环节,提出了完善、加强监管工作制度、机制的措施和建议,有助于进一步提升医疗器械经营监管工作的针对性和有效性。
<<The newly revised Regulations on the Supervision and Administration of Medical Devices(hereinafter referred to as the Regulations)will be implemented on June 1 2021. The Regulations continue to retain the basic institutional provisions governing the operation and supervision of medical devices. In this paper,through the investigation of the problems encountered by some provincial bureaus in Beijing,Shanghai,Hunan,Shaanxi,Gansu,Henan and other provinces in the actual supervision of medical device management links,the ideas to be solved and constructive suggestions for work,some problems that restrict the development of market subjects,can be solved through the implementation of principal responsibilities and the experience of overseas advanced management. Aiming at the weak links found in the practice of supervision,this paper puts forward some measures and suggestions to perfect and strengthen the supervision system and mechanism,so as to further enhance the pertinence and effectiveness of the medical device management and supervision work.
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