医疗器械监督抽检品种遴选的分析与思考

Analysis of Variety Selection for Medical Device Supervision and Inspection

摘要: 该文从医疗器械监督抽检品种的遴选过程、遴选原则入手，结合2017—2019年的国家医疗器械抽检品种具体分析遴选品种的考虑因素，并通过对医疗器械分类目录和体外诊断试剂目录进行梳理，对遴选品种提出有关建议，为今后遴选品种提供了抽检品种库以供参考。

Abstract: This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and in vitro diagnostic reagents.