纳米医疗器械产品及监管进展

Nanomedical Device Products and Regulatory Progress

目的:为了解纳米医疗器械的产品、国内外监管和标准化工作进展提供参考。方法:通过查阅国内外资料,从纳米医疗器械的产品、国内外监管现状、国内外标准化工作等方面进行全面的分析和总结。同时结合作者课题组在纳米医疗器械安全性评价领域所做的研究工作,总结相关的标准转化工作。结果与结论:目前纳米医疗器械产品种类和标准均不多,许多新兴产品仍在不断发展中,相关的监管及标椎化工作需提前谋划布局,需要各方加强合作。

Objective:To provide reference for understanding the products,supervision and standardization of nanomaterial medical devices at home and abroad.Methods:By consulting the domestic and foreign data,the products,supervision status and standardization work of nanomaterial medical devices at home and abroad were analyzed and summarized comprehensively.At the same time,combined with the research work of the author's research group in the fi eld of safety evaluation of nanomaterial medical devices,the related standard conversion work was summarized.Results and Conclusion:At present,there are not many kinds of nanomaterial medical devices products and relevant standards.And many new products are still developing.The related supervision and standardization work should be planned in advance and layout.Cooperation amomg all parties should be strengthen.