Medical Device
Registration
in Brazil
Guidance and support for navigating ANVISA registration in Brazil:
Brazil is the largest medical device market in Latin America, supported by a well-structured, internationally aligned regulatory system. Before entering the market, medical devices, IVDs, and SaMDs must meet the requirements set by ANVISA, Brazil’s Health Regulatory Agency.
The registration path your product follows depends on its risk classification.
Defining this correctly is a key first step — and it sets the tone for the rest of the process.
Class I and II Devices – Notification
Devices in Classes I and II — including medical devices, IVDs, and SaMDs — follow a streamlined process called Notification. These lower-risk products don’t go through a full technical review by ANVISA before registration.
Still, the Agency may audit or request documentation at any time. That’s why your technical dossier must be complete and compliant — including product details, applicable reports, proposed Portuguese labeling, and instructions for use, all maintained by your Brazilian Registration Holder.
One big advantage? Class I and II registrations don’t expire.
At DOMO Salute, we help you compile and review your documentation, making sure everything is aligned with ANVISA’s expectations and ready for a smooth review — now or later.
Class III and IV Devices – Registro
Class III and IV products follow a more structured pathway that includes a full technical review by ANVISA. These applications typically require:
- Prior BGMP certification (Brazilian Good Manufacturing Practices);
- A complete technical dossier, including clinical data, performance tests, biocompatibility studies, and legal documents, among others;
- Labeling and instructions for use in Portuguese.
Once approved, registrations are valid for ten years.
We work closely with your team to define the right classification and prepare for each step of the process. Our goal is to make the path clear — from early planning to final submission.
Additional Certifications
Some devices may require additional certifications beyond ANVISA registration. INMETRO is mandatory for certain products, such as electromedical equipment, while ANATEL applies to those with wireless communication features like Bluetooth or Wi-Fi.
If your device falls into one of these categories, DOMO Salute can guide you through the certification process to keep your registration on track. Get the full picture.
Your Authorized Representative in Brazil
If your company doesn’t have a legal presence in Brazil, you’ll need an in-country Authorized Representative to hold and maintain your device registration. DOMO Salute can serve as your Brazilian Registration Holder, managing the registration process with ANVISA and ensuring ongoing compliance. Discover our hosting solution.