Colombia medical device registration requires regulatory approval from INVIMA, Colombia’s medical device regulator. There are two regulatory pathways, uncontrolled and controlled, with different documentation requirements depending on device classification. Foreign manufacturers must also appoint a Colombia-based Legal Representative.
Pure Global simplifies the process with AI workflows that accelerate INVIMA submission preparation, along with local support and representation, all for a flat annual fee.
Colombia's aging population is growing at 3.5% annually, outpacing total population growth (1.7%). By 2050, 27.5% will be 60+. This shift drives a rise in noncommunicable diseases.
Medical device and IVD registration in Colombia is governed by INVIMA and follows a risk-based framework under Decree 4725/2005 (medical devices) and Decree 3770/2004 (IVDs). Foreign manufacturers must appoint both a Legal Representative and a licensed importer with an INVIMA-issued CCAA, and all documentation must be submitted in Spanish.
Devices are classified into Class I, IIa, IIb, and III; IVDs are classified into Class I, II, and III. This classification determines whether they qualify for automatic approval or require full technical review.
Colombia offers two pathways: uncontrolled (automatic approval) for lower-risk devices and controlled (full review) for higher-risk products. IVDs follow the same pattern.
Uncontrolled Pathway (Automatic Registration): Class I and IIa devices follow the uncontrolled route. INVIMA grants immediate approval once documentation is filed, typically within days.
Controlled Pathway (Full Review): Class IIb and III devices follow the controlled pathway and require INVIMA to evaluate the technical dossier, clinical evidence, and labeling before approval. These reviews require additional time but vary depending on device risk, data volume, and any information requests.
Manufacturers must provide technical, safety, labeling, and quality documentation in Spanish, along with a Certificate of Free Sale and proof of QMS compliance, device descriptions, its intended use, components, materials, history, and performance characteristics.
A complete dossier generally includes:
Foreign manufacturers must appoint a Colombia-based Legal Representative to act as their liaison with INVIMA. This representative is responsible for submitting registration applications, renewals, and modifications; responding to inspections, audits, and inquiries from INVIMA; and acting on the manufacturer's behalf. The manufacturer holds the registration even they are not based in Colombia.
Foreign manufacturers must appoint a licensed importer with an INVIMA-issued Certificate of Storage and Conditioning Capacity (CCAA). The importer is responsible for import registrations, customs filings, storage compliance, and post-market vigilance reporting.
We provide turnkey regulatory support in Colombia, all for a flat annual fee:
Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.
In-country representation, with Pure Global serving as your Legal Representative.
Post-market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post-approval modifications, and renewals.
The cost of INVIMA registration through an in-country representative is usually between $2,000 and $3,000 per device, which includes government fees and translation costs. Costs can decrease when multiple registrations are filed at once. Companies should also budget around $5,000 per year for ongoing expenses such as representation fees, modifications, post-market surveillance, vigilance, and in some cases an annual CCAA charge. Renewal fees are generally no more than 50% of the original registration cost.
Use our Fee Calculator to estimate your market entry costs in Colombia.
INVIMA charges mandatory government fees based on product type (medical device vs. IVD) and risk classification:
For medical devices, application fees are as follows:
For in vitro diagnostics (IVDs):
A trademark application fee may apply if brand registration is required in Colombia. Trademark fees range from COP 1,288,000 to COP 1,714,500 (approximately USD 309) per application.
All fees listed are government fees only and do not include consulting services, dossier preparation, translations, or in-country regulatory representation. Additional fees may apply; government fees are subject to change without notice.
Use our Fee Calculator for up-to-date government fees in 14 markets.
Timelines vary based on device classification. For Class I and IIa devices, dossiers can be prepared and filed in about 3–4 weeks, with automatic approval from INVIMA upon submission. For Class IIb and III devices, the same preparation time applies, but INVIMA’s review and approval process typically takes 6–8 months. Once granted, registrations are valid for 10 years, except for Class III IVDs, which must be renewed every 5 years.
To achieve INVIMA Colombia registration, foreign manufacturers must appoint a legal representative in Colombia for registration submission to INVIMA and work with a CCAA certified importer for medical device importation. Understanding the device classification is essential for navigating the registration process effectively.
The registration renewal period for medical devices and IVDs in Colombia varies: Classes I and II medical devices have a 10-year renewal period, while Class III IVDs have a 5-year renewal period under INVIMA registration guidelines.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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