医疗器械许可事项变更分析及改进建议

Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items

摘要: 该文通过对河南省2017年7月—2018年11月完成的350件第二类无源、有源医疗器械许可事项变更技术审评工作进行统计，汇总分析了技术审评补正中的常见问题及其审评要求，并给出相关对策或建议，以期进一步加快医疗器械审评审批。

Abstract: Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.