bioaccess® provides end-to-end medical device registration and market access services across Latin American countries for companies with existing FDA-cleared or CE-marked products.
Brazil's ANVISA is the largest regulatory agency in Latin America, covering a 210M+ patient population. bioaccess® states it manages Class I–IV device registration through ANVISA's regulatory pathways.
Colombia's INVIMA offers a 60-day fast-track registration pathway for certain device classes. bioaccess® states it has 15+ years of INVIMA experience.
Mexico's COFEPRIS offers a 30-day abbreviated pathway (Vía Abreviada) for devices with existing FDA or CE approval. bioaccess® states it manages Class I–III registrations.
Argentina's ANMAT regulates medical devices under a risk-based classification system. bioaccess® states it manages provincial and national device registration.
Chile's ISP provides device registration pathways with recognition of FDA/CE data. bioaccess® states it manages the full ISP registration process.
Peru's DIGEMID regulates medical device imports and registration. bioaccess® states it manages DIGEMID registration and market entry.
bioaccess® states typical registration timelines of 90 days for low-risk devices and 120 days for Class II/III devices, depending on the country and device classification.