Apr 07, 2020

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 COVID-19 page for industry
AUSTRALIA TGA – See main COVID-19 page for industry

OTHER REGULATORY AUTHORITIES

Only English-language content shown below. Please visit individual regulatory authority websites for additional information that may be published in the native language.

European Commission guidance for manufacturers during COVID-19 – April 3
European Commission recommendations on conformity assessment and surveillance during COVID-19 – March 13
COVID-19 information for industry from France ANSM (mostly French)
COVID-19 information for industry from Germany BfArM (mostly German)

We realize there are MANY additional resources available on the websites of Competent Authorities worldwide. We will add additional links here as we become aware of them. If you have found a page that is relevant to medical device and IVD regulatory professionals, please email us.