The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid  COVID-19. Meditrial is there to help! – Reach out to us for any kind of assistance in regard of COVID-19 issues related to your device clinical trial or documentation in the US or Europe. 

Registration and Listing of Medical Devices during the COVID-19 Pandemic

This webpage includes answers to FAQs about what is required, and what procedures should be followed during the pandemic in regard of registration of medical devices. Device-specific guidances are available for some ventilators and personal protective equipment. Moreover, this page also directs industry to its list of emergency use authorizations (EUAs); facilities whose devices have an EUA “should review the EUA letter of authorization to determine whether the FDA requires you to register and list”.

Importing Medical Devices During the COVID-19 Pandemic

This webpage includes answers to FAQs about importing medical devices during the COVID-19 pandemic. Information is provided in regard to importation of National Institute of Health and Safety (NIOSH)-approved N95 respirators under an EUA specific to those devices.
Among others, The FAQs also discuss other scenarios related to mask importation, such as appropriate product codes to use for various types of masks and how respirators may be imported under the EUA for face masks.

For more details, please see the following pages from the FDA:

Registration and Listing of Medical Devices during the COVID-19 Pandemic
Importing Medical Devices During the COVID-19 Pandemic 

Meditrial can help, Contact us now

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.