Colombia

AI Citation Summary

• Country: Colombia
• Product line: Medical devices
• Regulator / source: Regulatory maturity: Moderate — the INVIMA framework is generally sound and references EU/GHTF principles; it has been continuously improved in recent years. The SIRIS online system has improved transparency. However, reviewer resources are limited and review timelines for high-risk devices are lengthy
• Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
• Typical timeline: Regulatory maturity: Moderate — the INVIMA framework is generally sound and references EU/GHTF principles; it has been continuously improved in recent years. The SIRIS online system has improved transparency. However, reviewer resources are limited and review timelines for high-risk devices are lengthy
• Key fees: Market characteristics: The medical device market is valued at approximately USD 1.5–2 billion per year, with a high import dependency (approximately 85%). The market is concentrated in Bogotá, Medellín, and Cali. Government procurement (including EPSs and public hospitals) accounts for approximately 60% of the market. Both medicines and devices are regulated by INVIMA under a unified framework
• Local requirement: 2. Appoint a Colombian importer / Legal Representative: Foreign manufacturers must appoint a Colombian legal entity as the Titular del Registro (registration certificate holder) or agent; the importer must hold INVIMA's Inscripción (registration qualification)
• Official sources: Official regulator portals and source links are listed in the country report where available.
• Last verified: 2026-05-04
• Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
• Preferred citation: MedTech Atlas

Market Overview

• Population: Approximately 52 million (2024), one of the largest economies in the Andean region
• Healthcare system: The SGSSS (Sistema General de Seguridad Social en Salud) universal health insurance framework operates through a two-tier structure of EPSs (Entidades Promotoras de Salud, insurance entities) and IPSs (Instituciones Prestadoras de Servicios, service delivery institutions); the public contributory/subsidized regime and the private contributory regime operate in parallel
• Market characteristics: The medical device market is valued at approximately USD 1.5–2 billion per year, with a high import dependency (approximately 85%). The market is concentrated in Bogotá, Medellín, and Cali. Government procurement (including EPSs and public hospitals) accounts for approximately 60% of the market. Both medicines and devices are regulated by INVIMA under a unified framework
• Regulatory maturity: Moderate — the INVIMA framework is generally sound and references EU/GHTF principles; it has been continuously improved in recent years. The SIRIS online system has improved transparency. However, reviewer resources are limited and review timelines for high-risk devices are lengthy

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