A South Korean medical AI software company was willing to expand its two (02) CAD SaMDs in multiple countries spread across various ASEAN, MENA, and LATAM regions. The SaMDs were moderate risk; the Ministry of Food and Drug Safety (MFDS), Korea approved; and CE marked in compliance with the European Medical Device Directive (EU MDD). However, the client was unaware of the Regulatory requirements for SaMDs in the countries in scope and required detailed country-specific RI reports for some countries and information on sole license holding policy for a few other countries. The deliverables were multidimensional, owing to multiple products, services, and countries in scope. With these challenges, the client approached Freyr for Regulatory Intelligence (RI), Device Registration, and Authorized Representative Services for their SaMDs.
How did Freyr overcome the challenges and provide multi-country RI, device registration, and authorized representative services for the client’s SaMDs? What were the client benefits? Read through this proven case.