我国医疗器械追溯体系建设模式探讨

Discussion on the Construction Mode of Medical Device Traceability System in China

目的:探索我国医疗器械追溯体系的建设模式。方法:通过梳理追溯体系概念、医疗器械追溯体系建设意义以及建设需求,从建设主体、各方职责及架构模式方面探讨我国医疗器械追溯体系建设模式。结果和结论:医疗器械追溯体系建设是一个多方参与和配合的过程,政府部门作为管理者,应制定追溯体系相关法律法规,推动UDI实施和信息标准建设。而企业作为追溯体系建设的主体责任单位,应主导建设追溯体系,既可以满足监管需求,又能最大化地提高企业积极性和创造性,有利于发挥追溯体系建设最大价值。

Objective:To explore the construction mode of medical device traceability system in China.Methods:This paper expounds the significance of the construction of medical device traceability system,and discusses the mode of medical device traceability system in China by analyzing the responsibilities of all parties.Results&Conclusion:The construction of medical device traceability system is a process of multi-party participation and cooperation.Government departments,as the regulator,should formulate relevant laws and regulations on traceability system to promote the implementation of UDI and the construction of information standards.As the main responsible unit of traceability system construction,enterprises should lead the construction of traceability system,which can not only meet the regulatory needs,but also maximize the enthusiasm and creativity of enterprises,and is conducive to the maximum value of traceability system construction.