Getting regulatory approval in Brazil feels like the finish line for many manufacturers. Months of preparation. Documentation. Technical files. Interactions with ANVISA. When the approval finally comes through, the natural reaction is simple: Great. Now we can start selling. But Brazil doesn’t quite work that way. Regulatory approval is important. Absolutely necessary. It’s just not the moment the market opens. In reality, approval is the moment the next phase begins. Approval allows entry. It doesn’t guarantee adoption. We’ve watched this pattern many times. A manufacturer receives ANVISA approval and expects the commercial process to move quickly. After all, the product is now legally authorized in the country. Hospitals should be ready. Distributors should be eager. Sales should follow. And yet, months later, adoption is slower than expected. Sometimes much slower. Why? Because hospital adoption in Brazil depends on a set of dynamics that exist beyond regulatory approval. Understanding those dynamics early makes an enormous difference. Hospitals don’t buy approvals. They buy solutions. From a regulatory perspective, approval means the product meets safety and performance requirements. From a hospital’s perspective, that’s just the starting point. Procurement teams, clinical committees,...
