May 26, 2021
EU MDR/IVDR
Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be...
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Dec 26, 2020
MHRA
The Medicines and Healthcare products Regulating Agency (MHRA) of the UK has updated its guidance for medical device manufacturers initially published in December 2014. In particular, the document provides additional clarifications and recommendations regarding how...
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Aug 18, 2020
FDA
The Food and Drug Administration (FDA or the Agency) has answered the most important questions related to importing, registration and listing of medical devices during the pandemic associated with the outbreak of the Coronavirus Disease 2019 (COVID-19). Importing...
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Jun 11, 2020
Europe
The Roszdravnadzor, the Russian federal authority responsible for medical devices regulation, issued recommendations on quality, effectiveness, and safety examination of medical software for the purpose of state registration under the national framework. Eligibility...
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May 14, 2020
Europe
The Russian Federation issued several regulations implementing additional measures to ensure and expand the availability of medical devices that are vitally important during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the...
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