Non-EU market access

In order to sell products outside the European Union, these products shall undergo conformity assessment procedures that differ from the standards in the European Union. We provide consulting and support in obtaining permits and registration in non-EU markets.

Market access UK

The agency responsible for the regulation of medical devices in the UK is the MHRA. If the manufacturer is based outside the UK, they should appoint a UK Responsible Person.

Market access Switzerland

MedDo/IvDO regulations require the appointment of an Authorised Representative for a manufacturer from the European Economic Area that is not based in Switzerland.

Market access USA

Before entering the market, all medical devices should be registered with the FDA (United States).

Market access Canada

Regulatory issues concerning medical devices in Canada is the responsibility of the Therapeutic Products Program at Health Canada.

Market access LATAM

Brazil is the largest medical device market in LATAM, with an established and complex regulatory and compliance system. National Health Surveillance Agency (ANVISA) is responsible for the surveillance of medical devices.