As the third-largest medical device market in Latin America, Colombia, with a population exceeding 50 million, presents a significant opportunity for international medical device companies. Over 80% of its medical devices and IVDs are supplied by foreign manufacturers, underscoring the importance of INVIMA Colombia Medical Device Registration for those looking to expand their footprint in this key market.
The EU Commission’s 2025 Economic Operator Survey examines medical device availability under MDR/IVDR using data from manufacturers, authorised representatives, importers, and distributors. It highlights certification delays, documentation challenges, and discontinuation of niche devices. The findings show increasing risks to EU supply continuity, emphasizing the need for early planning, complete technical documentation, and close collaboration with notified bodies.
This video breaks down the key factors that drive expenses and timelines so you can plan smarter, avoid delays, and align your strategy with your budget.
Explore articles and insights our team has published in leading media and industry platforms.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
