Brazilian Registration Holder
Looking to bring your medical devices into Brazil? The country has one of the largest and most dynamic healthcare markets in Latin America. But before your product hits the shelves, you’ll need to comply with Brazilian regulatory system.
Led by Anvisa, this process requires foreign manufacturers to appoint a Brazilian Registration Holder (BRH), a local legal representative responsible for regulatory compliance and vigilance activities.
From registration and communication with authorities to managing post-market responsibilities, we help streamline your market entry while keeping your product aligned with local regulations. We don’t just act as your BRH—we operate as an extension of your team in Brazil.
How We Support Your Regulatory Journey in Brazil
We help you navigate every layer of the Brazilian regulatory system with clarity and control?
Official Representation Without Local Entity: Don’t know how to register a company in Brazil? You don’t need to. As your Brazilian Registration Holder, Sobel acts as your authorized local representative, allowing you to sell your medical devices in Brazil without creating a subsidiary.
Vigilance Case Management: In the event of adverse events or product issues, we step in to coordinate responses with Anvisa. Our team gathers documentation, investigates the case, and manages communication with health authorities—ensuring timely and professional handling of all vigilance activities.
Distributor Qualification & Oversight: We help assess, qualify, and coordinate with local distributors to ensure they meet ANVISA standards and your internal quality expectations. You stay in full control of your commercial relationships while we handle the regulatory side.
Ongoing Compliance & Strategic Support: Regulatory demands evolve—and so does your business. As your operations grow, we offer additional services such as regulatory strategy, clinical evaluations, and biological risk assessments to support your long-term success in Brazil.
Why do you need this service?
Foreign manufacturers cannot register or sell medical devices in Brazil without a local representative authorized by Anvisa. We fulfill this role with full transparency and alignment to your goals.
Should any issues arise, such as product complaints or safety concerns, we act quickly and effectively to meet regulatory deadlines—protecting your product and your reputation.
With Sobel as your Brazilian Registration Holder, you maintain commercial independence. You can change distributors without losing your product registration.
Having a trusted Brazilian Registration Holder is about gaining a reliable partner who helps you navigate Brazil’s regulatory system with confidence. With the right local support, you reduce risk, speed up approvals, and protect your business every step of the way.
Looking for a Brazilian Registration Holder?
If you need a reliable partner to support your medical devices’ entry into the Brazilian market, Sobel is ready to help.
With Sobel as your local partner, you gain more than a legal representative—you gain a team that knows the regulatory system inside out, and is committed to protecting your product, your business, and your peace of mind.
Let us help you enter and grow in the Brazilian market—strategically, efficiently, and with full regulatory support.
Take the next step toward effortless regulatory compliance in Brazil!
