Policy Considerations on Promoting Simultaneous Market Approval of Imported Innovative Medical Devices in China
This paper reviews the time of 24 imported innovative medical devices approved in China since the implementation of the innovative medical devices registration procedure,and finds the average time lag is 4.4 years compared to their market launch in the United States,indicating a gap from the national advocacy of promptly introducing advanced products and encouraging global simultaneous market launches.To investigate the factors affecting the simultaneous market entry of imported innovative medical devices in China,this article outlines the processes and requirements for innovative medical device designation application,clinical trial filing and approval,and market application for innovative medical devices.A comparison is made with the marketing pathway for breakthrough medical devices in the United States.The comparison reveals that patent application,type testing,and clinical trial approval are the key stages that most likely contribute to the time lag in market approval,impeding China's participation in global multicenter clinical trials and collaborative research.Therefore,this article proposes relevant policy considerations and recommendations,including extending the designation validity duration of innovative medical devices,standardizing the pathways for device changes during the clinical stage,unifying the requirements for domestic and foreign applicants in clinical trial approvals,accelerating the local translation of international standards,improving the patent system,allowing innovative products set prices independently,and encouraging domestic enterprises to engage in overseas collaborations in multiple ways.
innovative medical devicesimultaneous marketingclinical trial approvaltype testingbreakthrough device
万方数据
维普
