Research and Reflection on the Coordinated Guidelines for Medical Devices Good Regulatory Review Practice Working Group of IMDRF
Objective:The Good Regulatory Review Practice(GRRP)Working Group has been working for 7 years to draft and publish 8 coordination guideline documents.This article aims to summarize and study the essence of a series of documents,and explore the development and advantages of international regulatory coordination of medical devices.Methods:The work situation of GRRP and the main content of the guideline document are sorted out,and the international experience and consensus gathered in the document are analyzed,as well as the implementation of the series of documents in China and member regulatory regions are explored.Results and Conclusion:The coordinated guideline documents developed by the International Medical Device Regulators Forum(IMDRF)GRRP working group on regulatory responsibilities,the structure and process of decision-making by conformity assessment bodies,and product safety and effectiveness has been fully implemented in China,which meets the new needs of China's medical device innovation regulatory development and reflects China's proactive efforts in international regulatory coordination.
medical device conformity assessment bodyinternational medical device regulators forumgood regulatory review practice
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