Brazil's health agency, ANVISA, has just launched a new digital portal, ending weeks-long delays for essential medical device certificates. This major shift from paper to a fully online system promises to accelerate market access, enhance transparency, and slash the administrative burden that has long frustrated manufacturers trying to enter Latin America's largest market.

This episode breaks down what this digital transformation truly means for the industry. Consider a company whose multi-million dollar product launch was stalled for two months, not by regulatory hurdles, but by the wait for a single, physical GMP certificate. We explore how the new instant, online process eliminates this critical bottleneck, changing the game for logistics, sales, and getting vital medical technology to patients faster.

**Key Takeaways:**

* Which specific certificates are now available through ANVISA's new digital portal?

* How does this change impact the timeline for post-approval market launch in Brazil?

* What are the immediate operational steps your company must take to use this new system?

* Does the digital certificate hold the same legal weight for customs and distributors?

* How can this move signal broader digital transformation trends within other LATAM agencies?

* What are the potential cybersecurity concerns with a fully digital certification process?

* Are there new fees associated with these online requests compared to the old system?

At Pure Global, we offer end-to-end regulatory solutions to navigate these changes seamlessly. Our local experts in Brazil and advanced AI tools streamline market access, from registration strategy to post-market surveillance. Let us help you turn regulatory updates into a competitive advantage. Contact us at [email protected] or visit https://pureglobal.com/.