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近年来,企业研发用于除皱的透明质酸钠类面部注射产品日益增多。此类产品在国内按照第三类医疗器械进行管理,即属于管理类别最高的医疗器械,注册申报时需提交规范的临床试验资料以支持其安全性和有效性。因此,对于此类产品如何进行科学的临床试验设计,如何选择合理的临床评价标准,如何按照不同的产品适应证界定临床试验单元,如何对临床数据进行充分的分析,以及对于已上市的产品如何进行临床随访数据的收集,则是企业和临床试验机构共同关注的问题。
In recent years, companies research and development for the wrinkle of sodium hyaluronate facial injection products are increasing. Such products in the country according to the third category of medical devices to manage, which belong to the highest management category of medical devices, the registration declaration required the submission of standardized clinical trial data to support its safety and effectiveness. Therefore, how to design a scientific clinical trial for such products, how to choose a reasonable clinical evaluation standard, how to define clinical trial units according to different product indications, how to fully analyze clinical data, and how to market the products The collection of clinical follow-up data is a matter of common concern for both companies and clinical trial agencies.