EU → BR · medical devices
Bringing medical devices into Brazil from Germany
In short
Entering Brazil with medical devices from Germany 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.
The regulatory path
ANVISA RDC 751/2022
Notification or full registration by risk class; the timeline scales with class.
26–40 wks
BPF / local representation
Good manufacturing evidence and a Brazilian Registration Holder.
varies wks
Recommended entry model
Brazilian Registration Holder model — and decide carefully whose name the registration sits in.
Top risks on this route
- 01Risk-class surprises that multiply the registration timeline.
- 02Registration held by a distributor you cannot later unwind.
- 03Clinical/technical file gaps discovered late.
Der Opportunity Scan · 5 Minuten
Is this your route? Scan it before you commit.
A 5-minute scan returns an operator-reviewed readout tailored to your product and corridor — move, test, or not yet.
5 Min.Scan starten →Related routes
Geschäftsinformationen, keine Rechts- oder Steuerberatung.