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China revises registration procedure for imported and high-risk domestic devices:

This article was originally published in Clinica

Executive Summary

China's State Food and Drug Administration (SFDA) has revised the standard registration procedure for all imported medical devices and domestic class III (highest-risk category) devices. Registration now comprises three elements: application acceptance by the SFDA's administrative service centre; a technical assessment, conducted by its Center for Medical Devices Evaluation; and the SFDA's administrative approval. It also specifies registration criteria and time limits, according to a summary statement issued by the agency on July 30.






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