借鉴欧盟新版医疗器械法规引入医疗器械第三方评审机制的思考与建议

The Suggestion of Introducing the 3rd Party Review System by Reference of EU New Medical Device Regulations

摘要: 为提升医疗器械审评效率和审评质量，欧盟通过第三方审评机构（公告机构）对医疗器械实施技术审评工作。2017年5月欧盟颁布实施了新版医疗器械法规，对负责医疗器械技术审评的第三方审评机构提出了更加严格和细致的要求。该文研究了欧盟新法规对第三方审评机构监管的最新要求，结合中国医疗器械技术审评现状，对我国引入医疗器械第三方技术审评机制提出相关建议。

Abstract: In order to improve the efficiency and quality of medical device review, EU adopts the third party organization-Notify Body (NB) to review the medical device. EU promulgated and implemented new Medical Device Regulation (MDR) on May, 2017, claimed more severe and detailed requirements to the third party review organizations. This paper tries to provide suggestions on introducing medical device the third party review system in China by researching the new requirements of the NB in MDR and taking consideration of China current medical device technical review situation.