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The New Work Item Proposal "Update the List of International Standards Recognized by IMDRF Management Committee Members" was Approved by IMDRF
2018-03-28

On March 22,2018,in the 13th International Medical Device Regulators Forum (IMDRF) Management Committee (MC) meeting,the new work item proposal “Update the List of International Standards Recognized by IMDRF Management Committee Members”put forward by China was unanimously approved,which is a historic breakthrough since China has changed its role from a participant to a leader in the rulemaking of international standards recognition in the medical devices area.It also marks new progress made by China in continuously and in-depth promoting the Chinese experience in medical device standards management.
As an important technical support to the regulation of medical devices,international standards play a significant role in ensuring the safety and effectiveness of medical devices and improving the regulatory efficiency.This new work item proposed by China will update the list of international standards recognized by IMDRF members since 2014 and further analyze the similarities and differences in related policies and techniques of members when they adopt or recognize international standards.The intended research results of this proposal will lay a solid foundation for exploring the best practice of international standards recognition,promoting mutual recognition of standards and achieving the harmonization of international medical devices regulation.

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