Our Global Regulatory Coverage

North America

United States — FDA 510(k), PMA, De Novo, IDE, UDI, Establishment Registration, US Agent services

Canada — Health Canada medical device licenses, MDEL, CMDCAS

Europe

European Union — CE marking under MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746), including technical file compilation, Notified Body liaison, and EU Authorized Representative services

Switzerland — Swissmedic registration and Swiss Authorized Representative

United Kingdom — UKCA marking and UK Responsible Person services

Asia-Pacific

Japan (PMDA), Australia (TGA), South Korea (MFDS), Singapore (HSA), India (CDSCO), Philippines, Indonesia, Malaysia, Thailand, Vietnam, Pakistan, Uzbekistan, Bangladesh, New Zealand

Hong Kong (MDACS), Macau

Middle East & Africa

Saudi Arabia (SFDA), Ghana, South Africa, Egypt, UAE, Ethiopia, Morocco, Kenya, Nigeria

Latin America

Brazil (ANVISA), Argentina, Mexico, Chile, Peru, Colombia, Venezuela, Costa Rica, Panama

Eurasian & CIS