Unlocking MedTech in Colombia: A Pure Global Guide to INVIMA's Fast-Track Notification for Low-Risk Devices in LATAM

In this episode of LATAM MedTech Insights, we demystify the "automatic" registration process for low-risk medical devices in Colombia. We explore the requirements set by the national regulatory body, INVIMA, for Class I and IIa devices, detailing the specific documentation needed for a successful and speedy market entry.

We break down why this streamlined pathway is a major advantage for MedTech manufacturers targeting the Colombian market. Learn how to leverage your existing approvals and what common administrative errors can cause significant delays, turning a fast-track process into a frustrating roadblock.

Consider the case of a scale-up company with an innovative Class IIa device. They targeted Colombia for its efficient "automatic" registration, hoping for a quick launch. However, their submission was rejected. The reason was a simple administrative oversight: their translations were not officially certified and their home country approval lacked the required Apostille. This small error cost them an entire quarter of lost sales and market momentum, a painful lesson in the importance of local regulatory details.

What You'll Learn:
1. What does INVIMA's "automatic" registration for low-risk devices really mean?
2. Which specific device classes are eligible for this streamlined process in Colombia?
3. What is the single most critical document you need from your home country to even begin?
4. Why can a simple mistake in document legalization derail your entire submission?
5. How can you ensure your Spanish translations meet INVIMA's strict requirements?
6. What are the key components of the technical dossier required for a Class I or IIa device?
7. How quickly can you start selling in Colombia after a successful submission?
8. What is the role of a local representative in this notification process?

At Pure Global, we specialize in transforming these complex regulatory hurdles into clear pathways for market access. Our end-to-end solutions, combining local LATAM expertise with advanced AI tools, ensure your submission is right the first time. Stop letting paperwork stand in the way of your expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your entry into over 30 global markets.