Covid-19

In these days, we are suffering from Covid-19. Every individual or business are aware of Covid-19 outbreak. On this page you can find recent updates about regulations, directives, standards related to products that can be used during Covid-19 treatment.

Europe

Recently, European Commission of European Union published a guide: Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

On this guide, you can find responses to many questions related to medical devices and its regulations in Europe.

European Commission also published IMDRF Standards Checklist modified in scope of COVID-19. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

On this list you can see Document Reference (standards) and how to apply them in European Union (EU), Australia (AU), Brazil, Canada, China, Japan, Russia, Singapore, South Korea and US. Click here to download IMDRF Standards Checklist modified in scope of COVID-19

USA

FDA of US is also informing the community about Covid-19.

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. One of the EUAs is Coronavirus Disease 2019 (COVID-19) EUA Information.

Are you importing Covid-19 supplies to US?

Shipment of COVID-19 supplies held-up at a port-of-entry? You can make the process easier. For assistance, contact the FDA office covering your port of entry. Click here for more details.