摘要
从监管体系角度,介绍美国食品药品监管局对组合医疗产品的全生命周期管理所采取的监管措施及相关要求,结合我国药械组合产品的管理现状,探讨建立适应我国实际的药械组合产品监管体系的思路,以期在科学把控风险、落实有效监管的基础上,促进药械组合产品行业的创新发展。
On the basis of introducing FDA’s regulatory measure and relevant requirement for life-cycle management of combination product,this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product’s current situation,in order to promote innovative development of relevant industries.
作者
董谦
田蒙
母瑞红
DONG Qian;TIAN Meng;MU Ruihong(National Institutes for Food and Drug Control,Beijing,102629;Beijing Northern Hospital of Weaponry Industry,Beijing,100089)
出处
《中国医疗器械杂志》
2021年第6期670-673,共4页
Chinese Journal of Medical Instrumentation
基金
中国食品药品检定研究院2020年度中青年发展研究基金(2020G2)。
关键词
组合医疗产品
药械组合产品
监管体系
combination product
drug-device combination product
supervision system
