Inside Brazil’s MedTech Market: What Global Companies Need to Know

An interactive deep dive into Brazil’s fast-evolving MedTech landscape, from regulatory frameworks and clinical development to market access and commercialization strategies.

Join Bruno Oliveira (Director of Marketing & Business Development, MSC MED) and Sean Smith (Publisher & Founder, MedTech Leading Voice) as they explore how Brazil regulates, tests, and commercializes medical technologies, including updates on ANVISA, RDC 751, MDSAP, and emerging clinical and reimbursement pathways.

You’ll gain a clearer view of the opportunities, risks, and strategies needed to succeed in one of the most dynamic MedTech markets in Latin America.

💡 You’ll Learn:
• How ANVISA regulates device classification, registration, and changes under RDC 751.
• MDSAP adoption and its impact on Good Manufacturing Practice (GMP) audits.
• Clinical study approval timelines and ethics committee coordination.
• Market access, reimbursement, and reliance models under IMDRF.
• What U.S. and EU manufacturers should know before expanding into Brazil.

🎙️ Featuring:
• Bruno Oliveira, Director of Marketing & Business Development, MSC MED
• Sean Smith, Publisher & Founder, MedTech Leading Voice

⏱️ Chapters
(00:00) – Welcome & introductions
(03:29) – Overview of Brazil’s MedTech landscape
(04:21) – About MSC MED and Bruno Oliveira’s background
(06:34) – Brazil’s growth, market size, and regional hub status
(07:36) – Key regulatory frameworks: ANVISA, RDC 751, and MDSAP adoption
(09:23) – Data insights: 173,000 devices registered in Brazil (NyquistAI)
(13:55) – Panel introductions: Michelle, Martin, Jose, and more
(16:13) – Understanding RDC 751, RDC 74/2020, and RDC 848 for IVDs
(18:27) – GMP certification, MDSAP benefits, and renewal cycles
(21:07) – Clinical investigations: timelines, ethics committees, and parallel submissions
(27:19) – Market demographics & population concentration
(29:14) – Importation rules, reconditioned devices, and technovigilance
(31:07) – Growing U.S. interest in Brazil’s MedTech opportunities
(36:45) – MDSAP’s impact on foreign vs. domestic manufacturers
(44:31) – Role of Inmetro & Anatel in device testing and certification
(49:02) – Regulatory hot topics: reusable devices, PMS reform, and innovation
(50:40) – Reimbursement strategies: CONITEC, ANS, and market access
(54:53) – Innovation and startup growth in Brazil’s MedTech ecosystem
(56:38) – Reliance models under IMDRF for market acceleration
(59:17) – Key risks, grouping rules, and reimbursement alignment
(1:00:23) – Final recommendations and practical takeaways
(1:01:15) – Closing remarks & upcoming sessions

About Bruno Oliveira and MSC MED
Bruno Oliveira is a seasoned Regulatory, Quality, and Clinical Affairs leader with 15+ years of experience guiding MedTech companies through complex market pathways across Latin America, Europe, and the U.S.
At MSC MED, a Brazilian-based medical engineering and technology consultancy, he helps global device manufacturers plan and execute regulatory, clinical, and technical strategies that accelerate market access.

ℹ️ About Friday In-Focus
Friday In-Focus is MLVx’s weekly webinar series always free, always interactive spotlighting MedTech’s most experienced thinkers and doers.

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