建立医疗器械产品分类界定工作新模式的探索与实践

目的使医疗器械企业和监管部门更全面地了解分类界定工作程序和相关要求,做好分类界定工作。方法分析以往分类界定工作中的主要问题,解析新的分类界定工作流程、申报材料要求以及申请途径,并重点介绍《医疗器械分类规则》修订等基础性工作的研究进展。结果与结论建立完善科学的分类界定工作模式,将有效提高分类界定工作的效率和质量。

Exploration and Practice of the Development of a Scientific Process for Medical Device Classification

Objective To help manufacturers and regulators to comprehensively understand procedures and corresponding requirements of the classification system.Methods On the basis of the analysis of the main problems in the past classification work,the new procedures of classification including the detailed workflow,as well as the relevant requirements for application materials and the ways to apply were introduced,and the research progress in some relevant fundamental work was highlighted,such as the revision of ＂Medical Device Classification Rules＂.Results and Conclusion The establishment of the scientific classification system will effectively improve the efficiency and quality of the work.