试论医疗器械监管

The Current Problems of Regulation of Medical Devices and Countermeasures

目的为进一步加强医疗器械监管提供参考。方法分析医疗器械监管存在的薄弱环节。结果与结论要从立法、理念、基础建设、队伍建设、监管模式和宣传等方面入手,使医疗器械市场逐步走上规范化、法制化的轨道。

Objective To further enhance the regulation of medical devices for reference. Methods The existing weak links of medical devices were analyzed. Results and Conclusion From the legislation,ideas,infrastructure,team building,supervision and promotion patterns and other aspects,the medical device market has gradually step onto the standardization and legal system of the track.