整形与美容医疗器械临床试验风险管理探讨

Discussion on the risk management of clinical trials of plastic and aesthetic medical devices

整形与美容行业发展迅速,相关医疗器械产品逐年增加。由于国内目前医疗器械临床试验管理制度有待进一步完善,部分合同研究组织合规意识较差,导致一些劣质产品流入市场。文章从整形与美容医疗器械临床试验的特点出发,在系统本身和临床试验过程两个层面对整形与美容医疗器械临床试验中可能存在的风险进行探讨并提出建议,为相关人员提供借鉴和参考。

The plastic surgery and beauty industry is developing rapidly,and related medical equipment products are increasing year by year.As the current domestic medical device clinical trial management system needs to be further improved,some contract research organizations have poor compliance awareness,resulting in some inferior products entering the market.Starting from the characteristics of the clinical trials of plastic and cosmetic medical devices,this article discusses the possible risks in the clinical trials of plastic and cosmetic medical devices at both the system itself and the clinical trial process,and provides suggestions and reference for relevant personnel.