摘要
目的讨论取消医疗器械生产企业许可证制度的必要性。方法从现有制度、监管部门和市场主体三方面分析我国医疗器械生产企业许可证制度,并对比分析国外医疗器械的监管方式。结果医疗器械生产企业许可证制度存在弊端,不能适应市场经济的发展。结论应借鉴国际通行做法,实行医疗器械产品注册许可,取消生产企业许可证制度。
Objection The article discusses the necessity of current medical device manufacturing licence system. Methods It analyzed the current system from the law, the government and the manufacturers, and contrasts the system of developed countries. Results The system existed some problems and couldn＇t adapt to market economy development. Conclusions It suggests that the government cancel current medical device manufacturing licence system and enforce product licence.
出处
《中国药事》
CAS
2009年第7期627-629,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
生产企业
许可证
medical devices
manufacturers
licence
