药械组合包装中配用未经注册医疗器械案件的办理及思考

目的探讨对药械组合包装中医疗器械的有效监管措施。方法以一起药械组合包装中未经注册的第二类医疗器械案件为例,对办案过程中遇到的问题和监管难点进行系统分析。结果必须进一步加强对药械组合包装中医疗器械的监管。结论应采取细心收集证据、与生产厂家充分沟通、与供应商积极协调、加强从业人员培训等措施,切实加强对药械组合包装中医疗器械的监管,以维护医疗器械市场的正常秩序,保证公众使用医疗器械安全有效。

Handling and Thinking on One Case of Unregistered Medical Device in Drug-device Combination Package

Objective To explore effective regulatory measures for medical devices in drug-device combination package.Methods Taking one case of a drug-device combination package containing an unregistered Category II medical device as an example,the problems encountered and regulatory difficulties during case handling were analyzed.Results Supervision on medical devices in combination package must be further strengthened.Conclusion Measures should be taken including careful collection of evidence,adequate communication with manufacturers,active coordination with suppliers,enforced training of personnel and so on,in order to maintain the normal order of the medical device market and ensure the safe and effective use of medical devices for the public.