对我国医疗器械监管完善之思考

Reflections on the Regulation Improvement of Medical Devices

医疗器械安全关系到广大人民群众的生命安全和身体健康,必须严格加以监管。我国的医疗器械监管目前主要依据是《医疗器械监督管理条例》。虽然2014年修订后的条例通过增加处罚种类、细化罚则等方式较大提升了监管水平,对于完善我国医疗器械监管体系具有重要意义。但是由于立法层次低、监管力量单一等原因,导致医疗器械管理中仍存在不少问题。该文试从多方面就医疗器械规范管理的完善提出一些建议。

The safety of medical devices is related to the life safety and health care of masses, which must be strictly regu-lated. The medical device regulation in our country is mainly based on the ＂Supervision and Regulation of Medical De-vices＂. Generally speaking, the 2014 revised regulations have greatly improved the regulatory level by increasing the types of penalties and detailing the rules, which has important significance for improving China＇s medical device regulatory sys-tem. However, due to the reasons of low legislative level and single force of regulatory, etc, many problems still existed in medical device management. In this paper, it puts forward some suggestions of improving the standardized management of medical devices.