新形势下医疗器械抽查检验管理规定的修订

On Revision of Regulation for Sampling Inspection of Medical Devices under the New Situation

目的:探讨医疗器械抽检有关规定的修订要点。方法:对医疗器械监管特别是抽检所面临的新形势进行整理,对现行医疗器械抽检有关规定的不足和问题进行归纳,对修订要点的可行性和影响进行分析。结果:提出了修订《医疗器械抽查检验管理办法》的若干建议。结论:监管机构应当充分认识当前医疗器械监管形势的变化,及时总结经验教训,调整定位并主动作为,将修订医疗器械抽检有关规定提上日程。

Objective:To discuss the main points of revision of relevant regulations for sampling inspection of medical devices.Methods:New situation of medical device regulation,especially sampling inspection was sorted out.Shortcomings and problems of the current regulations for sampling inspection of medical devices were summarized.Feasibility and impact of major feasible aspects were analyzed.Results:Some suggestions for revising the Regulations for Sampling Inspection of Medical Devices were put forward.Conclusion:Regulator authorities should be well aware of the current changes in the regulatory situation of medical devices,timely summarize the lessons learned,adjust the positioning and take the initiative,put the revisions of the relevant regulations on sampling inspection of medical devices on the agenda.