HOW WE HELP

Your
brazilian
regulatory team

Expert In-Country Representation for seamless market entry and ongoing compliance.

Appointing a trusted Brazilian Registration Holder (BRH), also known as your Authorized Representative, is crucial to successfully entering the Brazilian market. With DOMO Salute as your in-country regulatory partner, you’ll gain peace of mind knowing that your product registrations are in expert hands while you stay in control of your market strategy.

By choosing an independent local representative like DOMO Salute, you maintain full ownership of your
registrations—without the need to transfer control to a distributor. This provides the flexibility to select the best distributors, adjust your distribution channels, and adapt to local market conditions, all while keeping your strategy aligned with your business objectives.

What it means to have DOMO as your local regulatory partner

In-Country Representation

We act as your official authorized representative in Brazil, managing ANVISA registrations and ensuring
compliance while you focus on growing your business.

Post-Market Surveillance

We handle complaints, adverse event reporting, and corrective actions, ensuring that your product meets
safety standards and remains compliant with Brazilian regulations.

Renewals and Market Adaptation

We take care of renewals, registration updates, and monitor regulatory changes. We provide timely
notifications, keeping your business agile and compliant.

Import Authorizations & Compliance

DOMO Salute issues import permits for your chosen distributors, working closely with them to ensure they meet the necessary qualifications for the importation process.

Want to know what
it’s like to work
with us?

Hear directly from the companies we’ve helped bring to the
Brazilian market.

Read their stories

How we help

Medical Device Registration in Brazil

Seamlessly navigate Brazil’s regulatory landscape with our support in registering your medical devices, including SaMD and IVDs, efficiently.

Your brazilian regulatory team

Whether you call us your Brazilian Registration Holder or Authorized Representative, DOMO Salute manages every certification and regulatory requirement for ANVISA, INMETRO, and
beyond.

INMETRO & ANATEL Certification support

Receive expert assistance in managing the certification processes for your electromedical equipment and related devices, facilitating a smooth market entry.

BGMP Certification management

We guide you through the process of preparing and submitting the necessary documentation for compliance with Brazilian Good Manufacturing Practices (BGMP) standards, ensuring quality and safety.