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Listen "LATAM's New Breath: Navigating Brazil's Ventilator Surplus and Mexico's Regulatory Maze in Respiratory MedTech with Pure Global."
Episode Synopsis
In this episode of LATAM MedTech Insights, we move beyond the headlines of the pandemic to uncover the real state of the respiratory device market in Latin America. The urgent rush for ventilators has subsided, leaving behind a complex landscape of equipment surplus, shifting clinical needs, and formidable regulatory barriers. We explore how the focus is moving from emergency ICU equipment to long-term solutions for chronic conditions like COPD and sleep apnea, creating new opportunities for agile MedTech companies.
Imagine you are a MedTech innovator with a cutting-edge respiratory device, ready to tap into the burgeoning Brazilian market. Your launch is stalled for months because the regulatory body, ANVISA, rejects your submission on a technicality that was buried in local-language guidelines. This common but costly scenario is the focus of our discussion, highlighting how navigating the unique regulatory maze of each LATAM country is the key to success.
What you'll learn in this episode:
1. Why is the post-pandemic ventilator surplus a multi-million dollar opportunity for service and maintenance companies?
2. How is the demand for home-care respiratory devices changing the market in Mexico and Argentina?
3. What are the top 3 regulatory mistakes foreign companies make when submitting to ANVISA in Brazil?
4. Why is securing a local registration holder in Colombia so difficult and what are the risks?
5. Are local manufacturers a credible threat to established international brands?
6. How can you leverage your existing FDA or CE mark for a faster pathway in countries like Peru and Chile?
7. What specific clinical data do LATAM regulators want to see for respiratory devices?
8. How is telehealth integration becoming a key differentiator for new products in the region?
At Pure Global, we transform these regulatory complexities into clear market access strategies. We provide end-to-end regulatory consulting and act as your official local representative in over 30 markets, including Brazil, Mexico, and Colombia. Our combination of local experts and advanced AI tools streamlines the submission process to authorities like ANVISA and COFEPRIS, getting your products to market faster. Don't let bureaucracy block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to get started.
Imagine you are a MedTech innovator with a cutting-edge respiratory device, ready to tap into the burgeoning Brazilian market. Your launch is stalled for months because the regulatory body, ANVISA, rejects your submission on a technicality that was buried in local-language guidelines. This common but costly scenario is the focus of our discussion, highlighting how navigating the unique regulatory maze of each LATAM country is the key to success.
What you'll learn in this episode:
1. Why is the post-pandemic ventilator surplus a multi-million dollar opportunity for service and maintenance companies?
2. How is the demand for home-care respiratory devices changing the market in Mexico and Argentina?
3. What are the top 3 regulatory mistakes foreign companies make when submitting to ANVISA in Brazil?
4. Why is securing a local registration holder in Colombia so difficult and what are the risks?
5. Are local manufacturers a credible threat to established international brands?
6. How can you leverage your existing FDA or CE mark for a faster pathway in countries like Peru and Chile?
7. What specific clinical data do LATAM regulators want to see for respiratory devices?
8. How is telehealth integration becoming a key differentiator for new products in the region?
At Pure Global, we transform these regulatory complexities into clear market access strategies. We provide end-to-end regulatory consulting and act as your official local representative in over 30 markets, including Brazil, Mexico, and Colombia. Our combination of local experts and advanced AI tools streamlines the submission process to authorities like ANVISA and COFEPRIS, getting your products to market faster. Don't let bureaucracy block your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to get started.
More episodes of the podcast LATAM MedTech Insights
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23/09/2025
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