对国家医疗器械监督检验工作的分析和思考

Analysis and Reflection on the Current Situation of National Medical Device Supervision and Inspection

目的为医疗器械上市后监管决策提供参考。方法对国家医疗器械监督检验工作中遇到的问题进行了系统的分析和讨论。结果与结论提出加强信息化建设、提高标准质量、建立科学合理的医疗器械标准体系等建议,对上市后产品监管体系建设的设想进行了探讨。

Objective To offer reference for decision-making for post-marketing supervision of medical device. Methods The problems encountered in the testing for the state quality supervision of medical devices were analyzed and discussed. Results and Conclusion Suggestions such as strengthening informatization construction, improving the quality of standard, and establishing scientific and reasonable standard system of medical device were put forward, and suggestions for post-marketing supervision were also discussed.