摘要
药械组合产品具有特殊性,如何建立质量管理体系,如何对质量管理体系进行有效监管是个值得探讨的问题。该文对国内外体系监管现状分析药械组合产品质量管理体系建设及监管中存在的问题,给出相关意见建议,以期为相关企业的体系建立及监管部门提供参考。
Combination products have special characteristics,how to establish quality management system and how to effectively supervise the quality management system is a problem worth discussing.The paper analyzes the existing problems in the quality management system construction and supervision of combination products from the current situation of system supervision at home and abroad,and gives relevant suggestions,in order to provide reference for the system establishment and supervision departments.
作者
刘凤林
柴谦
郭金双
张云娟
杨阳
董丹丹
陈洪忠
LIU Feng-lin;CHAI Qian;GUO Jin-shuang;ZHANG Yun-juan;YANG Yang;DONG Dan-dan;CHEN Hong-zhong(Shandong Center for Food and Drug Evaluation and Inspection,Shandong Jinan 250000;State Key Laboratory of Structural Chemistry,Fujian Institute of Research on the Structure of Matter,Chinese Academy of Sciences,Fujian Fuzhou 350002)
出处
《中国医疗器械信息》
2022年第13期10-12,共3页
China Medical Device Information
关键词
药械组合产品
质量管理体系
监管
combination product
quality management system
supervision
