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), and De Novo classification, depending on the device's risk level. In Canada, Health Canada regulates medical devices through its Medical Device Regulations under the Food and Drugs Act, requiring device licensing and establishment registration. Meanwhile, in Latin American countries such as Brazil, Mexico, Colombia, and Argentina,...
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), and De Novo classification, depending on the device's risk level. In Canada, Health Canada regulates medical devices through its Medical Device Regulations under the Food and Drugs Act, requiring device licensing and establishment registration. Meanwhile, in Latin American countries such as Brazil, Mexico, Colombia, and Argentina, regulatory authorities like ANVISA and COFEPRIS implement their own approval processes, typically involving device classification, local representation, and product registration.
