Navigating Colombia's Medical Device Regulatory Landscape

As the third-largest medical device market in Latin America, Colombia, with a population exceeding 50 million, is a significant import market for medical devices and IVDs, with over 80% supplied by foreign manufacturers. This highlights Colombia as a key market for international medical device companies seeking to expand their footprint in Latin America.

Device Classification and Regulatory Pathways

Understanding Device Classifications and Regulatory Requirements in Colombia

Regulatory Authority

The National Food and Drug Surveillance Institute (INVIMA) oversees medical device regulations in Colombia, governed by Decree 4725/2005 for medical devices and Decree 3770/2004 for IVDs. All medical devices and IVDs to be imported or distributed within Colombia require registration and approval from INVIMA.

Classification

  • Medical Devices: Classified into Classes I, IIa, IIb, and III based on risk, following 18 specific rules. The classification determines the registration process, with low-risk devices granted automatic registration and high-risk devices requiring a thorough review by INVIMA.
  • IVDs: Classified into Classes I, II, and III based on risk, with the classification process guided by 4 specific rules. The registration renewal period varies, with a 10-year renewal for Classes I and II and a 5-year renewal for Class III.

Key Requirements

To market in Colombia, foreign manufacturers must:

  • Appoint a legal representative in Colombia for registration submission to INVIMA.
  • Work with a CCAA certified importer for device importation.
  • Understand the classification to navigate the registration process effectively, with renewals every 10 years for medical devices and varying for IVDs based on class.
How We Can Help

Tailored Support for Market Entry

Our comprehensive services are designed to facilitate your market entry into Colombia:

  • Classification and grouping of your products to identify the regulatory pathway.

  • Preparation and compilation of the technical dossier for INVIMA registration.

  • Acting as your local representative for the INVIMA submission, assisting with the CCAA certified importer requirement, and ensuring compliance with post-market regulations.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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