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Colombia offers structured registration routes for Medical Devices, but INVIMA approval is only one step. Importer responsibilities, documentation and UDI-DI (Unique Device Identifier – Device Identifier) readiness should be aligned before commercialization.
Colombia’s Medical Device Market Growth Supports Expansion
Colombia is already one of Latin America’s larger Medical Device markets. ProColombia projects the market to exceed USD 2.2 billion by 2030, while the country remains highly dependent on imports: Medical Device imports reached approximately USD 1.37 billion in 2025. ProColombia also identifies Colombia as the third-largest Medical Device market in Latin America, after Brazil and Mexico.
The market opportunity is supported by rising healthcare demand and a comparatively transparent regulatory pathway. INVIMA publishes risk-based registration routes with stated processing periods of 2 business days for Class I and IIa devices and 90 business days for Class IIb and III devices. Colombia has also adopted a national Medical Device policy and continues to strengthen technology assessment, surveillance and traceability.
INVIMA Medical Devices: Registration Depends on Risk Class
INVIMA medical devices are classified as Class I, IIa, IIb or III according to risk. Class I and IIa devices that qualify for the automatic route can obtain registration within approximately 2 business days after filing, while Class IIb and III devices follow a regulatory review route with a timeframe of up to 90 business days.
In Vitro Diagnostic devices (IVDs) are products such as reagents, calibrators and control materials used to analyse human samples and provide diagnostic information. In Colombia, IVDs follow a separate risk structure: Categories I and II use an automatic registration route, while Category III products undergo higher-risk review.
Medical Device Import Colombia: Importer Responsibilities
Registration alone does not make a product ready for commercial launch. Before entering the market, Med-Tech manufacturers and importers should align:
- Product classification and the applicable INVIMA registration route.
- Technical and legal documentation, including product and labelling information.
- Registration-holder, importer and local representation responsibilities.
- CCAA requirements for relevant storage or conditioning activities.
- Import, traceability and distributor responsibilities.
Figure 1. Medical Device Import Colombia: Importer Responsibilities
These responsibilities should be clarified early, particularly when the manufacturer relies on a local importer or distribution partner.
What is Colombia UDI?
Colombia UDI refers to Unique Device Identification (UDI), a coding system that supports the consistent identification and traceability of Medical Devices and In Vitro Diagnostic products throughout the healthcare and distribution chain.
Colombia has adopted UDI-DI (Device Identifier), the component of the UDI that uniquely identifies a specific device version or model. UDI-PI is not reported under the Colombian system. The registration holder or its authorized party is responsible for reporting the required UDI-DI information to INVIMA.
Companies should therefore align UDI-DI, GMDN information, registration details, manufacturer information and commercial product data as part of market-entry preparation. For newly granted registrations subject to the current requirements, this reporting must be completed before commercialization.
Align Registration, Import and UDI Before Market Entry
For medical device import Colombia, a practical sequence is to confirm product classification, define the registration and importer model, close documentation gaps, address CCAA requirements where applicable, complete registration and finalize the applicable UDI-DI reporting.
Connecting these regulatory steps with local partner and distribution planning can reduce rework and support a more structured launch in Colombia and the wider Andean market.
Chameleon Pharma Consulting Group (CPC) has over 20 years of experience in supporting Pharma, OTC, Medical Devices, Phyto, and Aesthetic Medicine companies. Having established own offices & local hubs across Latin America, Europe, Asia, the US/Canada, the Middle East, and the CEE/CIS regions is another advantage of CPC. With this local network and expertise gained from 300+ international projects and a team of 25 experts we offer our clients:
- Business Development, M&A, and Due Diligence
- Market Entry & Expansion: Systematic product and country analysis, market reports
- Strategic Partnering: Identifying local partners, acquisitions, or setting up own offices
- Regulatory & Registration: for drugs, MD, Derma, Aesthetic Medicine, etc.
- Market Authorization & Compliance: Holding MAs, conducting pharmacovigilance
- Quality & Certification: GMP certification, pre-GMP audits
Contact us today for your individual request at service@chameleon-pharma.com!
