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China issues interim rules on adverse incident reporting and re-evaluation

This article was originally published in RAJ Devices

Executive Summary

China’s State Food and Drug Administration has issued an interim regulation that strengthens adverse event reporting requirements for medical device manufacturers, distributors, medical institutions and end users, product technical evaluation agencies, SFDA provincial offices and other relevant agencies1,2. The new rules also introduce the first-ever device re-evaluation procedures. Though the regulation came into effect on 30 December, it is expected to be updated in the future with a more comprehensive version.

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