『Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.』のカバーアート

Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.

Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.

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 In this episode of LATAM MedTech Insights, we dive deep into the unique regulatory landscape of Colombia, a pivotal market for any device manufacturer looking to enter Latin America. We uncover how INVIMA's dual-track system offers a strategic gateway for MedTech companies that know how to leverage it. We explore the powerful "automatic registration" pathway for low-risk devices that can get your product to market and generating revenue faster than you think. We also break down the complexities and extended timelines associated with the rigorous pre-approval process for high-risk technologies, and how to plan for them effectively. A Case for Strategy: Imagine trying to launch your entire device portfolio, from simple monitors to complex implants, into a new continent at once. The pain point is the immense upfront cost and the years of waiting for approvals before seeing a single dollar in return. One company flipped this challenge on its head. They launched their Class I device in Colombia in just a few months, using the immediate cash flow to fund the lengthy, data-intensive registration for their groundbreaking Class III product. This is how a regulatory landscape becomes a competitive advantage. This episode's key takeaways: 1. What is Colombia's "automatic registration" and which specific devices qualify? 2. How can a fast-track for low-risk products actually fund your entire LATAM expansion? 3. What are the most common documentation pitfalls that lead to rejection in an "automatic" submission? 4. How do you prepare a technical dossier for a high-risk Class III device that satisfies INVIMA's stringent review? 5. Why is a staggered, portfolio-based market entry strategy essential for success in Colombia? 6. How does your Colombian approval act as a potential stepping stone for other LATAM markets? 7. What are the critical roles and responsibilities of a local Legal Representative in the INVIMA process? At Pure Global, we specialize in transforming complex regulatory landscapes into clear, actionable market access strategies. Our teams of local experts, powered by advanced AI and data tools, offer end-to-end solutions for MedTech and IVD companies. Whether you are navigating Colombia's INVIMA for the first time or expanding across the continent, we streamline your path to market. Ready to build your LATAM strategy? Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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