Brazilian Registration Holder for Medical Devices
To register and sell your medical devices in Brazil, foreign manufacturers must appoint a Brazilian Registration Holder (BRH), a local entity authorized by Anvisa to represent their products. Let Sobel act as your Regulatory Representative in Brazil, ensuring your product remains compliant, your vigilance responsibilities are met, and your business stays in full control of local operations.
- Foreign manufacturers without a legal entity in Brazil.
- Companies seeking to commercialize medical devices under Anvisa’s regulation.
- Businesses looking for transparent, long-term regulatory representation in Brazil.
Whether your device requires INMETRO certification or not, Sobel provides end-to-end representation and ongoing support, acting as your bridge between global operations and Brazilian authorities.
Why do you need this service?
Brazilian regulation requires every foreign manufacturer to appoint a Brazilian Registration Holder, to represent their medical devices in the country.
Having a reliable representative ensures compliance with local vigilance obligations and communication with authorities.
This partnership reduces regulatory risks, protects your market access, and provides full transparency throughout your device’s lifecycle in Brazil.
Bring your medical device with a trusted Brazilian Registration Holder
With Sobel, you don’t just gain a local representative — you gain a strategic partner who understands both regulatory and business perspectives.
Efficiency and compliance, from start to finish.
Brazilian Registration Holder: with or without INMETRO
The Brazilian Registration Holder service is available in two modalities, depending on your product’s regulatory pathway:
BRH with INMETRO:
Required for medical electrical equipment or devices that fall under INMETRO certification scope. This option includes full representation aligned with both Anvisa and INMETRO requirements.
BRH without INMETRO:
Suitable for medical devices that are not subject to INMETRO certification. Focused solely on Anvisa representation, vigilance, and distributor qualification activities.
Need help identifying which applies to your product? Our team provides initial guidance to define the correct path and avoid compliance delays!
Related
Services
Entering the Brazilian market can unlock major opportunities. And if you’re getting ready to take this step, you may also be interested in:
Medical Device Registration and Notification
Notification, registration, and updates under RDC 978/2025 and RDC 658/2022.
Quality Management System
Align your QMS in Brazil with ISO 13485 and RDC 665/2022 requirements.
Biological Evaluation
Reliable, cost-effective biological evaluation documents aligned with ISO 10993 and Anvisa requirements.
Start your journey with a reliable Brazilian Registration Holder
Our team combines deep Anvisa expertise with transparent communication and proactive compliance management — helping your product stay aligned, approved, and competitive in one of the world’s most promising healthcare markets.
Partner with Sobel to secure a strong regulatory foundation in Brazil!
1. What is a Brazilian Registration Holder (BRH)
A Brazilian Registration Holder is a local legal representative authorized by Anvisa to act on behalf of a foreign medical device manufacturer. The BRH holds the product registration, manages vigilance activities, and ensures compliance with Brazilian regulations.
2. Do I need a Brazilian Registration Holder to sell my medical device in Brazil?
Yes. Foreign manufacturers cannot register or commercialize medical devices in Brazil without a local representative authorized by Anvisa. The BRH serves as your official contact for all regulatory communications and post-market responsibilities.
3. What is the difference between BRH with and without INMETRO?
Devices that fall under INMETRO certification scope — such as electrical or electromedical equipment — require a BRH with INMETRO. Other devices, not subject to INMETRO, can proceed with a BRH without INMETRO, focused solely on Anvisa representation and vigilance.
4. Can I change my Brazilian Registration Holder later?
Yes. Sobel’s process ensures commercial independence, allowing you to change distributors or representatives without losing your product registration — as long as the necessary regulatory updates are performed.
5. Does Sobel offer importation or distribution services?
No. Sobel acts exclusively as your regulatory representative before Anvisa, handling compliance, vigilance, and distributor qualification — but not importation or sales operations.
6. How long does the BRH service remain valid?
The representation remains valid as long as you wish to keep your device registered in Brazil. Sobel maintains ongoing compliance, renewals, and vigilance support throughout the product’s lifecycle.
