Brazil's MedTech Pulse: Fresh Registration Insights for 2025 Q2

Medical Device Global Market Access

This episode delves into the latest medical device registration data from Brazil, focusing on trends observed in March and April 2025. We explore the prevalence of Class I and II devices, particularly in diagnostics, the types of higher-risk Class IV devices gaining approval, and the manufacturing landscape, highlighting both strong domestic production and key international players from countries like China, Germany, and the USA. The host discusses specific device categories and the implications for manufacturers looking to enter or expand in the Brazilian market.

Key Questions:

• What types of medical devices are most frequently registered in Brazil according to recent 2025 data?

• Which risk classes dominate the Brazilian medical device landscape?

• Are Class IV devices being approved, and what are some examples from early 2025?

• How significant is domestic manufacturing versus international sourcing in Brazil's MedTech sector?

• Which countries were key exporters of medical devices to Brazil in early 2025?

• What does the recent data reveal about the demand for diagnostic products in Brazil?

• What are the key takeaways for MedTech companies considering the Brazilian market based on Q1 2025 insights?

• When were these highlighted device registrations primarily published or updated?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of Brazil’s ANVISA process—and 30+ other markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.