The Medical Device Policy Division of the Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices` regulation, announced the enforcement of the new regulation on in vitro diagnostic (IVD) medical devices. The law No. 163433...
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Apr 23, 2020
Europe
The European Commission, the EU authority responsible for medical device regulation, issued guidelines dedicated to the diagnostic tests used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. The...
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The International Medical Device Regulators Forum (IMDRF), an association composed of medical device regulating authorities, proposed new principles of classification of the in vitro diagnostic medical devices. The organization itself is focused on the development and...
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Mar 4, 2020
North America
The US Food and Drug Administration (FDA), the authority responsible for medical device regulation, issued guidance intended to assist the manufacturers of In Vitro Diagnostic Devices (IVD) in filing applications for the CLIA Waiver. CLIA Waiver: The Scope of...
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Feb 13, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
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