摘要
随着医疗器械行业的飞速发展和创新医疗器械的不断涌现,产品的上市后监督(PMS)越来越受到企业、认证组织和政府监管部门的重视。最近发布的ISO 13485:2016也反映了这个趋势,在多个条款上增加和细化了对上市后监督的要求,加强了与主流法规体系(例如美国FDA)的协调性。本文分析了新版ISO13485在上市后监督方面与旧版的差异,并就如何在新标准的框架下构建上市后监督管理体系作了探讨。
With the rapid development of medical device industry and the emergence of innovative medical devices, post-marketing surveillance（PMS） is being paid more and more attention by manufacturers, certification bodies and regulatory agency. ISO 13485：2016 has been published lately, and this new standard also reflected this trend. Many PMS requirements are included in the new standard to better harmonize with existing regulatory system（e.g FDA）. The author analyzed the gap of PMS between new and old version of ISO 13485, and provided recommendations on establishment of PMS system under framework of the new standard.
出处
《中国医疗器械信息》
2016年第8期5-9,共5页
China Medical Device Information
