LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

Many MedTech innovators see their FDA approval or CE mark as a golden ticket to Latin America, often targeting Chile first due to its reputation as an accessible market. However, the ground rules are changing fast. What was once a largely voluntary system is now shifting to a mandatory registration framework for all medical devices, creating new hurdles for unprepared companies. This episode of LATAM MedTech Insights dives into the reality of entering the Chilean market today. We uncover why your existing certifications are not a direct passport for sales but are the critical foundation for a successful regulatory submission to Chile's health authority, the ISP. What you'll learn in this episode: - Why was Chile historically considered an "easy" market in LATAM, and why is this no longer true? - Is registration with the ISP now mandatory for all medical devices? - Can I sell my device directly in Chile if it has FDA 510(k) clearance? - What is the role of a Certificate of Free Sale (CFS) in the Chilean registration process? - How does the ISP review technical dossiers based on CE marking or FDA approval? - What are the biggest mistakes companies make when entering the Chilean MedTech market? - Do I need a local legal representative or registration holder in Chile? - How long does the registration process typically take for a device with prior CE/FDA approval? Navigating the nuances of market access in Chile and across Latin America requires local expertise and a strategic approach. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, acting as your local representative and using advanced AI tools to streamline global market access. Let us help you turn your existing approvals into successful registrations. Contact us at [e-mail] or visit https://pureglobal.com/.