【作者】 邢花； 张倩； 李荏苒；

【Author】 Xing Hua;Zhang Qian;Li Renran;Shenyang Pharmaceutical University;

【机构】 沈阳药科大学；

【摘要】 目的:提出完善医疗器械管理法律法规的一些建议,以供政策制定者借鉴和参考。方法:详细解读我国目前正在实施的医疗器械相关法律法规,深入分析其中存在的不足之处。结果与建议:虽然国家已经颁布了《医疗器械注册管理办法》、《医疗器械生产监督管理办法》、《医疗器械经营监督管理办法》、《医疗器械监督管理条例》等法律法规,涉及范围相对广泛,但在条款中还是存在漏洞,这些漏洞给了某些不法企业可乘之机,使医疗器械频频出现不良事件,危害人们身体健康。因此,应该在颁布医疗器械相关法律法规的同时,更应该完善已出台的法律法规,尽可能做到每一个字都具有法律约束力,找不到漏洞,真正做到不仅理论完善,实践中也具有较强的执行力。更多还原

【Abstract】 objective:put forward some Suggestions to perfect the laws and regulations of medical equipment management,to provide reference for the policy makers.? Methods:by detailed interpretation current relevant laws and regulations of medical equipment of our country’s implementation to analyze the existing deficiencies deeply.The results and Suggestions:Although china has promulgated " measures for the administration of medical device registration"," medical devices supervision and administration of production method"," the supervision and administration of medical devices management method"," regulations on the supervision and administration of medical devices" and other laws and regulations,involving relatively extensive,but there are still loopholes,which gave some illegal enterprises chance,result in the frequent occurrence of adverse events of medical equipment.It harms people health.Therefore,at the same time of medical apparatus and instruments related laws and regulations promulgated,it should be more perfect in the current laws and regulations as far as possible,do every word is legally binding,no loophole.Make the laws not only perfect in theory,also has strong execution in practice.更多还原