Abstract:In this article, we took the special approval procedure for innovative medical devices as the entry point for the new policy,
and combined with the revised contents of the special approval procedure on china’s innovative medical devices (revised draft for
comments), to summarize the opportunities and challenges of domestic innovative medical devices under the environment of the
release of the new policy. Then we summarized the coping strategies of government and enterprise under the new environment,
aiming to provide some references to the supervision and industry development of medical device in China.
杨辉,胡凯. 新政策下国产创新医疗器械的机遇与挑战[J]. 中国医疗设备, 2019, 34(2): 161-164.
YANG Hui, HU Kai. Opportunities and Challenges of Domestic Innovative Medical Devices Under the New Policy. China Medical Devices, 2019, 34(2): 161-164.