This episode explores the medical device registration process in Colombia, focusing on the timelines set by the regulatory authority, INVIMA. We break down the key differences between the standard (controlled) review pathway for high-risk devices and the expedited (automatic) process for lower-risk devices, including eligibility requirements and realistic time-to-market estimates for each. This is essential information for any MedTech company considering market entry into Colombia.

- What is INVIMA and what is its role in regulating medical devices in Colombia?

- How long does the standard review process for Class IIb and III medical devices typically take?

- What is the expedited or automatic registration pathway in Colombia?

- Which device classes are eligible for the faster, automatic registration process?

- What is a Certificate of Free Sale and why is it crucial for expedited entry?

- Which foreign approvals does INVIMA recognize for its fast-track process?

- How can manufacturers leverage existing FDA or CE approvals to speed up Colombian registration?

- What are the realistic, real-world timelines for both the standard and expedited pathways?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies entering markets like Colombia. Our experts develop efficient regulatory strategies, leveraging pathways like INVIMA's automatic registration to accelerate your time-to-market. We manage the entire process, from compiling the technical dossier with AI-powered tools to acting as your local legal representative. With a presence in over 30 markets, we can turn a single registration process into multi-market access. To learn how we can help your company access global markets faster, visit us at https://pureglobal.com/, contact [email protected], or explore our FREE AI tools and database at https://pureglobal.ai.