Medical device registration in the Americas involves a diverse set of regulatory frameworks, with each country maintaining its own medical device classification systems, approval pathways, and market access requirements. In the United States, the Food and Drug Administration (FDA) oversees device approvals through processes like 510(k) premarket notification, PMA (Premarket Approval),... https://www.freyrsolutions.com/medical-devices/medical-device-registration-in-the-americas