Question 1

What is INVIMA and why is it important for medical device companies?

Accepted Answer

INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is Colombia's National Food and Drug Surveillance Institute, the regulatory authority equivalent to the FDA or EMA. As a decentralized entity under the Ministry of Health and Social Protection, INVIMA regulates medical devices, IVDs, pharmaceuticals, and health products in Colombia's expanding medical device market. All medical device companies must obtain INVIMA sanitary registration and maintain compliance to sell products in Colombia.

Question 2

What are the most important regulations for medical devices in Colombia?

Accepted Answer

Key regulations include: Decree 4725/2005 (regulatory framework for medical devices), Decree 3770/2004 (IVD regulatory framework), and Resolution 1405/2022 (UDI-DI requirements for device identification and traceability, mandatory by February 8, 2026 for Class IIa, Class I, and Category I IVDs). This page tracks all major decree and resolution updates from premium regulatory intelligence sources.

Question 3

What is the INVIMA automatic approval pathway?

Accepted Answer

INVIMA offers automatic approval for Class I and IIa medical devices (uncontrolled pathway). Companies can submit a complete technical file and receive immediate certificate issuance, allowing imports to begin right away. Class IIb and III devices (controlled pathway) require formal INVIMA review and approval, typically taking 6-8 months before sales can commence. This streamlined process makes Colombia an attractive entry point into Latin America.

Question 4

What is Colombia's UDI-DI system and when does it take effect?

Accepted Answer

Colombia introduced UDI-DI (Unique Device Identifier - Device Identifier) requirements through Resolution 1405 of 2022. The regulation is mandatory for most devices now, with Class IIa, Class I, and Category I IVDs required to comply by February 8, 2026. INVIMA recognizes UDI codes from globally accepted organizations including GS1, HIBCC, ICCBBA, IFA, Ali Health, and ZIIOT. The system improves device traceability and patient safety aligned with international standards.

Question 5

How often does INVIMA publish new regulations and updates?

Accepted Answer

Under Director Francisco Rossi's leadership (since February 2024), INVIMA has accelerated its reform efforts to streamline regulatory processes and reduce backlogs. In February 2025, INVIMA launched a new nomenclature and coding platform for medical devices. This page aggregates INVIMA news from 7 premium commercial sources to provide daily updates on regulatory changes, reform initiatives, and enforcement actions affecting the Colombia medical device market.

Question 6

What is a Colombia Registration Holder (CRH) and do I need one?

Accepted Answer

A Colombia Registration Holder (CRH), also called an Authorized Representative, is a legal entity based in Colombia required for foreign medical device manufacturers without a physical presence in Colombia. The CRH acts on behalf of the manufacturer in all regulatory interactions with INVIMA, including sanitary registration, post-market surveillance, and compliance activities. All foreign companies must appoint a CRH to register and sell medical devices in Colombia. Learn more in our CRH selection guide.

Question 7

How can I stay updated on INVIMA regulatory changes?

Accepted Answer

This page automatically aggregates INVIMA and Colombia medical device news from 7 premium regulatory intelligence sources daily, including RAPS, Pacific Bridge Medical, Emergo by UL, and others. Pure Global provides comprehensive regulatory support for Colombia market access.

Question 8

What sources does this INVIMA news page aggregate from?

Accepted Answer

We aggregate Colombia and INVIMA news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Pacific Bridge Medical, Emergo by UL, Asia Actual, Citeline MedTech Insight, Pure Global's proprietary Colombia research team, and Qualtechs. All sources are filtered to show only Colombia-related regulatory updates using advanced keyword matching including INVIMA, Decree 4725, Resolution 1405, and Colombia-specific terminology.

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