How to Register a Medical Device with INVIMA in Colombia

This video provides a practical overview of the medical device registration process in Colombia, covering how to classify your device, compile a compliant technical dossier, appoint a local representative, and navigate regulatory submission with INVIMA, Colombia’s health regulatory authority. Whether you're preparing for your first Latin American launch or expanding your regional footprint, this guide outlines the key steps for entering Colombia’s fast-growing medtech market.

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Colombia is Latin America’s third-largest medical device market, with over 50 million residents and a rapidly aging population. Roughly 80% of medical devices are imported, creating significant opportunity for global manufacturers. With a projected market value of US $1.5 billion and a 5.7% CAGR, Colombia presents a strong, long-term growth profile, particularly in diagnostics, chronic disease management, and surgical technologies. But tapping into that opportunity requires INVIMA approval, which is mandatory before any product can be legally marketed in Colombia.

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Devices and IVDs are regulated under Decree 4725/2005 and 3770/2004, which define classification rules, technical documentation requirements, and post-market obligations. Products are assigned to Class I, IIa, IIb, or III based on risk, with varying expectations for clinical data, safety testing, and conformity assessment. Manufacturers must also appoint a local authorized representative to manage interactions with INVIMA and maintain ongoing compliance.

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Topics covered in this video include:

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• Colombia's Medical Device Market Overview
  A snapshot of market dynamics, demand drivers, and import trends shaping medtech growth.
• Regulatory Framework in Colombia
  Overview of INVIMA’s role, key decrees, and the core regulations governing device and IVD registration.
• Medical Device and IVD Classification and Requirements
  A breakdown of Colombia’s risk-based classification system and how it impacts submission strategy.
• Registration Steps and Compliance
  Step-by-step guidance on compiling your dossier, working with your local representative, and maintaining registration post-approval.
• How Pure Global Supports INVIMA Registration & Market Entry
  See how our Colombia-based team handles classification, dossier preparation, and regulatory submission with precision and speed.

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Need help registering with INVIMA?
Pure Global’s local and global teams provide full support across classification, documentation, authorized representation, and post-market compliance. Whether you’re new to Colombia or scaling across LATAM, we simplify regulatory access so you can stay focused on innovation. Contact us to learn more about Colombia medical device registration.

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