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No matter how hard your team works, the lack of time is delaying your product’s market entry. We are Passarini Group — your extra team of specialists to optimize processes, secure certifications, and accelerate your registrations. Stop losing time to bureaucracy. Talk to us.

What do Mexico, Argentina, Peru, Colombia, and others have in common? They urgently need your medical product! 📢 Don't let the complexity of multi-country regulation hold back your global growth. Many see LATAM as a bureaucratic maze, but with Passarini Group, it becomes a simple, single path. With 20+ years of expertise, we specialize in simplifying the regulation of medical equipment across the region. Stop risking compliance delays. Talk to the Passarini Group today and secure rapid market access in the most dynamic economies in Latin America. #MedicalDevices #LATAMExport #RegulatoryAffairs #MarketAccess #Mexico #Colombia

You may be missing a golden opportunity due to fear of bureaucracy. Don’t waste any more time! Passarini Group simplifies the regulation of medical devices and ensures your fast entry into this massive market. Your expansion starts with one click. Talk to us.

Want to export to LATAM? Passarini makes your regulatory process simple. Talk to us.

Good News for the Industry! ANVISA Speeds Up AFE and AE: Understand the Impact (and the Risk) ANVISA has taken a major step toward cutting bureaucracy, and your company needs to be aware of this change! The issuance of the Certificates of Authorization to Operate (AFE) and Special Authorization (AE) is now done automatically through the Solicita system. What used to take days can now happen in just minutes!

Entering Europe can be a dream for many healthcare companies, but access requires a crucial passport: the CE Marking. The big question is: how can you ensure compliance and legal representation without letting regulatory challenges drain your time and resources? Passarini Group has the complete solution for your global growth — a true One Stop Shop!