Oct 29, 2021
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
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Apr 23, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has published a guidance document dedicated to the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to the In...
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Nov 2, 2015
North America
The difference between CLIA and FDA standards
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