摘要
注册检验是第二类和第三类医疗器械产品注册上市前的强制性检验程序,中国医疗器械检验服务市场发展较落后,第三方检验机构发展缓慢。针对当前医疗器械注册检验主要由官方医疗器械检验机构完成,导致政企主体责任不分、行业检验需求难以满足的问题,建议在厘清监管部门和行业企业的关系基础上,从自我检验、委托检验、检验机构角色转型等途径来革新现行医疗器械注册检验制度。
The registration inspection is a compulsory inspection procedure for Class Ⅱ and Class Ⅲ medical device products before registration and marketing. The development of China’s medical device inspection service market is relatively backward,and the development of third-party inspection agencies is slow. At present, the registration and the inspection of medical devices are mainly completed by official medical device inspection institutions, with the responsibilities of the government and the enterprises being mingled, and the industry inspection demand is difficult to meet. For clarifying the relationship between the regulatory authorities and the industry enterprises, it is suggested that the current medical device registration and inspection system should be reformed by using the self inspection, the entrusted inspection and the role transformation of inspection institutions.
作者
蒋海洪
张杰
张培茗
JIANG Haihong;ZHANG Jie;ZHANG Peiming(Shanghai University of Medicine&Health Sciences,Shanghai,201318,China;Shanghai University of Finance and Economics,Shanghai 200433,China)
出处
《科技导报》
CAS
CSCD
北大核心
2020年第22期25-30,共6页
Science & Technology Review
基金
中国药品监督管理研究会项目(CSDR-QXJG-2019-0005)。
关键词
医疗器械
注册检验
检验机构
委托检验
medical device
registration inspection
testing institutes
entrusted inspection
