Opening doors to
Brazil’s regulatory
landscape

BRINGING MEDICAL DEVICES, IVDs, AND SaMDs
TO THE BRAZILIAN MARKET WITH CONFIDENCE.

Your innovations in medical devices have the power to change lives.

At DOMO, we help you bring them to the Brazilian market with confidence.

Who we are

DOMO Salute is a regulatory consulting firm specializing in medical devices, IVDs, and digital health solutions. Our team combines deep local expertise with a global mindset, supporting each project with flexibility, precision, and a personal touch.

We’re not just a service provider—we’re your regulatory partner. From strategy to approval, every step is handled with clarity, dedication, and full alignment with your goals.

DOMO comes from the Latin word for house, and that’s exactly how we work: welcoming, collaborative, and focused on building trust.

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.

The Domo Way

Our approach is rooted in 3 key pillars:

01.

Personalized Guidance

We build personalized solutions by prioritizing your project’s unique objectives.

02.

Cutting-Edge Expertise

We simplify Brazilian market entry for innovative medical devices through regulatory and technological expertise.

03.

Open Communication

We empower partners through open communication and collaborative decision-making.

What they say

It has been a great pleasure for me to work with the DOMO Salute team. We have already developed several projects together, all with great success, leading to obtaining the product registration before the expected deadline. Quick answers, differentiated service, highly trained professionals! We [...]
– Marli Vieira – Regional Business Director Latin America, Gelita Medical GmbH (Germany)
Hear from them
We have been using DOMO Salute since July 2018, and I have to say that is has transformed the way we do registrations in Brazil.   DOMO Salute provides Med X Change with critical insight of the Brazil regulatory landscape, allowing us to make fast and educated decisions when it comes to [...]
– Edwin Martinez – Director of QA/RA, MedXChange (USA)
Hear from them
As an international network of companies and healthcare providers it is crucial to rely on professional and trustworthy partners. We are happy to have found this partner in DOMO salute with whom we have already registered various medical devices without any objections. We were also surprised [...]
– Tobias Zobel – Director of the Digital Health Innovation Platform (d.hip) and ambassador of the Medical Valley EMN (Germany)
Hear from them

Our People

The team behind the strategy—just a few of the experts moving things forward.

Diego Louzada

Business Development Manager
Diego, a mechatronic engineer and regulatory expert, founded DOMO Salute to streamline medical device registration, emphasizing strong communication. He values family, nature, and global connections through his work.

Thatiana Terroso

Regulatory Manager
Thatiana is an Industrial Pharmacist, has a PhD in Pharmaceutical Science and expertise in Nanotechnology and Innovation Management. She founded DOMO Salute, leveraging her deep regulatory knowledge and empathetic approach to facilitate medical device registrations in Brazil.

Amanda Frasson

Regulatory Manager
Amanda, a Biochemical Pharmacist with a PhD in Pharmaceutical Science, founded DOMO Salute, utilizing her analytical skills and regulatory expertise to guide clients through Brazilian market entry with a supportive and approachable style.

Thayse Terroso

Administrative & Finance
With a background in Business Administration and Design, specializations in Branding and Marketing, Thayse enhances DOMO Salute’s customer experience and brand presence. Her international experience fuels her passion for innovation and client-focused collaboration.

Insights & Updates

MDSAP Forum: Highlights Include Strategic Discussions, New Member Inductions, and Regulatory Developments
07/18/2024
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ANVISA’s Latest Guidelines and Regulatory Updates for UDI Compliance
07/02/2024
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ANVISA implements regulatory reliance mechanisms to streamline the evaluation process of medical devices already approved by Equivalent Foreign Regulatory Authorities (EFRAs)
04/12/2024
Read More