我国医疗器械生产监管现状分析

Analysis of the Current Situation of Production Supervision of Medical Devices in China

该文从医疗器械监管队伍、信用体系建设及《医疗器械质量管理规范》实施情况等方面介绍了我国医疗器械生产企业监管情况,提出了监管难点并给出监管建议。

The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation ofquality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals.