Non-EU countries

International Registrations and Approvals for Medical Devices and IVDs.

 

The commercialization of medical devices (MDs) and in vitro diagnostics (IVDs) in international markets can be a complex regulatory challenge. Indeed, each country has specific regulations governing their registration and approval.

For this, we, at FTR Advisor, support you with design, manufacturing and regulatory compliance activities, managing relationships with the Competent Authorities in each country to finalize the registration required to market the device.

 

We are able to follow registration procedures in major international markets, including:  

 

Saudi Arabia
Australia
Canada
China
Colombia
India
Malaysia
Mexico
Singapore
United States
Taiwan
United Arab Emirates