EU → BR · medical devices
Bringing medical devices into Brazil from France
En resumen
Entering Brazil with medical devices from France hinges on the regulatory path (ANVISA RDC 751/2022, BPF / local representation) and keeping registrations in your own name. Scan the route before you commit budget or sign a distributor.
La ruta regulatoria
ANVISA RDC 751/2022
Notification or full registration by risk class; the timeline scales with class.
26–40 sem.
BPF / local representation
Good manufacturing evidence and a Brazilian Registration Holder.
varies
Modelo de entrada recomendado
Brazilian Registration Holder model — and decide carefully whose name the registration sits in.
Principales riesgos en esta ruta
- 01Risk-class surprises that multiply the registration timeline.
- 02Registration held by a distributor you cannot later unwind.
- 03Clinical/technical file gaps discovered late.
El Opportunity Scan · 5 minutos
¿Es esta tu ruta? Escanéala antes de invertir.
Un escaneo de 5 minutos te devuelve un informe revisado por un operador, adaptado a tu producto y corredor — avanzar, probar o todavía no.
5 minIniciar el Scan →Rutas relacionadas
Inteligencia de negocios, no asesoramiento legal ni fiscal.