From May 19 to 22, Register Medical Group will be in Paris for EuroPCR 2026, one of the world’s leading events in interventional cardiovascular medicine.

The congress brings together physicians, researchers, innovators, manufacturers, regulatory specialists and healthcare leaders from around the world to discuss the future of cardiovascular care. For medical device companies, it is also a strategic environment to understand how innovation can move beyond clinical performance and reach new markets with safety, compliance and long-term commercial viability.

For international medtech companies, Brazil represents one of the most relevant healthcare markets in Latin America. However, entering the Brazilian market requires more than a strong product, a CE mark or successful adoption in other regions.

Brazil has its own regulatory pathway, its own technical requirements and a specific approval process led by ANVISA, the Brazilian Health Regulatory Agency.

Why Brazil Requires a Specific Regulatory Strategy

Many foreign manufacturers underestimate the complexity of bringing medical devices into Brazil.

A product approved in Europe or other international markets may still face important regulatory steps before it can be commercialized in São Paulo, Brasília, Rio de Janeiro or any other Brazilian region.

For cardiovascular devices, this pathway can involve:

  • ANVISA regulatory classification;
  • technical dossier preparation;
  • medical device registration or notification strategy;
  • GMP compliance requirements;
  • acceptance of MDSAP audits, when applicable;
  • local hosting and regulatory representation;
  • importation and commercialization planning;
  • post-market regulatory obligations.

This means that market access in Brazil must be planned early. Regulatory strategy should not be treated as a final step after product development or commercial negotiations. It should be part of the company’s international expansion strategy from the beginning.

RMG’s Role in Brazil Market Access

At Register Medical Group, we help international manufacturers understand, structure and execute the full regulatory pathway for Brazil.

Our work includes support with ANVISA registration, GMP acceptance via MDSAP, regulatory intelligence, dossier strategy, local hosting services and the practical steps required to place a medical device in the Brazilian market.

With more than 25 years of experience in Brazil and headquarters in Brasília, close to ANVISA, RMG combines technical expertise with a deep understanding of the Brazilian regulatory environment.

Our goal is to help companies reduce uncertainty, avoid unnecessary delays and build a compliant route to market.

EuroPCR 2026: A Strategic Moment for Medtech Companies

EuroPCR is more than a scientific congress. It is a meeting point for companies shaping the future of cardiovascular medicine.

For manufacturers exploring Brazil, revisiting their Latin America strategy or evaluating regulatory opportunities for cardiovascular technologies, EuroPCR 2026 is an ideal moment to start the right conversations.

Brazil is a market with significant demand for advanced healthcare solutions, but successful entry depends on preparation, regulatory clarity and the right local partner.

Let’s Connect in Paris

Register Medical Group will be at EuroPCR Paris 2026 to meet with companies, partners and innovators interested in understanding the Brazilian regulatory pathway.

If your team is developing, expanding or repositioning a cardiovascular medical device for international markets, let’s connect during the congress.

Brazil is a complex market, but with the right strategy, it can become a powerful opportunity for growth.

See you in Paris.