Duan Shimei, Zhong Zhizhen
Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.
Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Jan 30;47(1):80-82. doi: 10.3969/j.issn.1671-7104.2023.01.014.
Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
基于各省市第二类创新医疗器械审批及公示的现状，特别是在分析上海第二类创新医疗器械审评中发现的问题以及影响创新医疗器械上市进程的因素后，本研究提出了一些关于监管的思考，以供在建立和完善制度法规、转变审评审批思路、延伸服务至创新医疗器械研发及临床试验方案制定等方面参考。
