摘要
目的:为加强膏贴类医疗器械产品的监管提供参考。方法:对20批膏贴类医疗器械产品进行安全风险评估,从市场现状、风险监测结果和原因等方面阐述当前膏贴类医疗器械产品监管工作所面临的主要问题,并提出建议。结果:当前市场上膏贴类医疗器械的违规问题集中表现为虚假宣传助销、非法添加药物、伪造产品批文等。20批样品中有过半数的样品添加了药物成分,有的甚至混合添加了多种西药成分和中药成分。造成这种现状的原因主要有法律法规滞后、监管审查不严、巨额利益诱导等。结论:应完善法规、加强监管,统一审查标准、规范审批程序,并提高公众的相关知识和维权意识,以保障人民群众用械安全。
OBJECTIVE： To provide reference for the supervision of patch devices in China. METHODS： 20 batches of patch products were determined for security risk assessment. Major issues of patch devices were described from the market situation, result of risk supervision and reasons, and a few proposals were given out. RESULTS ： Main issues about illegal patch products involved false propaganda and stimulating consumption, illegal drug addition and forged official documents, etc. More than half of products involved drug among 20 batches, and some of them contained several kinds of western drugs and TCM. The situation was mainly induced by hysteretic laws and regulation, relaxed supervision and big benefit induction, etc. CONCLUSIONS： It is suggested to prefect regulation and supervision, unify review standard and standardize approval procedure by combination of policy instruments simultaneously to improve knowledge and consciousness of rights safeguarding of the public and guarantee the safety of devices use.
出处
《中国药房》
CAS
CSCD
2013年第44期4222-4224,共3页
China Pharmacy
关键词
膏贴
医疗器械
监管
问题
建议
Patch
Medical devices
Supervision
Issue
Proposal
