ANVISA pathway guide: Class I medical-device SaaS
Flowchart, step-by-step table with legal basis, document checklist and an indicative timeline for a foreign manufacturer entering Brazil.
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Practical guidance on ANVISA, distributor partnerships and the Brazilian healthcare market, drawn from twenty years on the ground.
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Global medical trade fairs overview
The 14 major B2B healthcare and medtech fairs by region, with dates of the next edition and headline figures.
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Short reads on how Brazil really works.
RDC 751Class I · II
Class I and II devices in Brazil: how ANVISA notification actually works
No prior technical review and a 30-day routine, but no second chance for an incomplete file. What you file, what you keep, and the details that catch foreign manufacturers.
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IN 290Class III · IV
FDA-cleared? How ANVISA's reliance route and MDSAP can speed up Class III–IV registration
Which foreign approvals ANVISA relies on (and why CE alone doesn't qualify), and how an MDSAP audit can replace the factory inspection.
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