dilluns, 21 de juliol del 2014

Malaysian medical device regulators change requirements for docs, AI requests




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.





Malaysian medical device regulators change requirements for docs, AI requests

By Stewart Eisenhart, Emergo Group


Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country.




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