COVID-19 Regulatory Resources for Medical Device and IVD Manufacturers

FDA and other global regulators have been rapidly publishing information intended to help manufacturers respond to the COVID-19 crisis. On this page we have posted helpful links to various Regulatory Authority webpages and other information specifically related to COVID-19. Please email us links to English-language web pages (useful to regulatory professionals) as you find them. Thank you! US FDA – See main COVID-19 page for industry UK MHRA – See main COVID-19 page for industry HEALTH CANADA – See main […]

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Get Your Medical Device or PPE on the EU Market to Help with COVID-19. Here’s How.

In the age of COVID-19, there may be confusion around how to get a medical device into the EU market to support European citizens grappling with this devastating pandemic. We are experiencing an exceptional event, and regulators know that they play a key role in getting life-saving medical devices and personal protective equipment (PPE) to market as quickly as possible. Manufacturers that have the desire and ability to ramp up their manufacturing capacity to fulfill unmet needs in the EU […]

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