dimarts, 10 de juny del 2014

IVD reagents to be regulated as medical devices in South Korea




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Staff changes at Indian regulator could boost review processes in the long term

By Stewart Eisenhart, Emergo Group


The South Korean Ministry of Food and Drug Safety (MFDS) plans to begin regulating in vitro diagnostic (IVD) reagents as medical devices instead of pharmaceutical products beginning in November 2014.




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