Market brief · Medical devices · 2026
Colombia is open to your medical technology: the device market entry guide
A US$1.8 billion medical device market that imports most of what it uses, and a regulator (INVIMA) that lets foreign manufacturers hold their own registrations. Here is what the numbers say, and how to enter while keeping your brand, your IP and your registration under your control.
The essentials
Key findings
- 01US$1.77Bis the size of the Colombian medical device market in 2025.1See it
- 0277%of the device market was covered by imports in 2025: US$1.37B.1See it
- 03+25%growth of the device market between 2025 and 2030, to US$2.22B.1See it
- 04US$81Min device exports in 2025, against US$1.37B in imports.1See it
- 05~6.45%yearly growth of low-complexity device production from 2014 to 2024, from US$112M to US$209M.1See it
- 064 hospitalsin Colombia rank in the top ten of Latam Best Hospitals 2024.1See it
- 07US$874in projected health spending per person in 2030, up from US$650 in 2025.3See it
- 0810 yearsof validity for a medical device registration before INVIMA.See it
- 09In your namethe INVIMA registration can stay, even if the manufacturer is foreign.See it
Chapter 1 of 6
A market built on imports, with a hub position in Latin America
Colombia's demand for medical technology is growing, and most of it is met with imports. ProColombia puts the device market at US$1.77 billion in 2025, heading to US$2.22 billion in 2030, while domestic production goes from US$345.5M to US$495.2M over the same period.1
- Demand outpaces local supply. Domestic production covers only about US$345M of a US$1.77B market. Hospitals rely on imported technology.1
- World-class buyers. Four Colombian hospitals rank in the top ten of Latin America's best hospitals, and more than 35,000 people graduated in health sciences in 2024.1
- A regional springboard. Over 85% of Colombia's US$388M in pharmaceutical exports went to Latin American markets in 2025.2
- A predictable regulator. Four risk classes under Decree 4725 of 2005, 10-year registrations and 100% online filing before INVIMA.
Medical device market vs. domestic production
US$ millions. The gap between the two bars is what imports cover today.
The device market grows by about US$444M to 2030, while domestic production adds about US$150M.
See the data
| Total market | Domestic production | |
|---|---|---|
| 2025 | US$1,773M | US$346M |
| 2030 (projected) | US$2,217M | US$495M |
How much of the device market is imported
US$ millions, 2025. Imports reached US$1,374M of a US$1,773M market.
About three of every four dollars spent on medical devices in Colombia go to imported products.
See the data
| 2025 | |
|---|---|
| Imports | US$1,374M |
| Rest of the market | US$399M |
Device imports and exports, 2025
US$ millions. Colombia buys far more medical technology than it sells abroad.
For every dollar of medical devices Colombia exported in 2025, it imported about seventeen.
See the data
| 2025 | |
|---|---|
| Imports | US$1,374M |
| Exports | US$81M |
Chapter 2 of 6
A local base: production, talent and buyers
Colombia also makes devices. Low-complexity production grew from US$111.7M in 2014 to US$208.7M in 2024, a compound annual rate of about 6.45%.1 BMI projects Colombia as the third-largest medical device market in Latin America, with 164 export-oriented device companies concentrated in Valle del Cauca, Bogotá and Antioquia.3
Low-complexity device production almost doubled in ten years
US$ millions. Compound annual growth of about 6.45% between 2014 and 2024.
Local production of low-complexity devices rose by about US$97M in a decade.
See the data
| Low-complexity device production | |
|---|---|
| 2014 | US$111.7M |
| 2024 | US$208.7M |
- Demanding buyers. Four Colombian hospitals made the top ten of the Latam Best Hospitals 2024 ranking: Fundación Santa Fe, Fundación Cardioinfantil, Fundación Cardiovascular de Colombia and Clínica Imbanaco.1
- Trained talent. 35,041 people graduated in health sciences in 2024.1
- Competitive costs. The hourly manufacturing wage was US$2 in 2024, according to Euromonitor data cited by ProColombia.1
- A large market. More than 53 million inhabitants.1
Health spending per person keeps rising
US$ per capita. Over the same period, health spending moves from 8.2% to 9.3% of GDP.
Spending per person rises by about a third between 2025 and 2030.
See the data
| Health spending per capita | |
|---|---|
| 2025 | US$650 |
| 2030 (projected) | US$874 |
Chapter 3 of 6
The decisive advantage: own your INVIMA registration
SPI structures the local representation so the registration stays in your name. If a commercial relationship ends, your device does not leave the market with it.
Chapter 4 of 6
A predictable regulator
Medical devices in Colombia are regulated by INVIMA under Decree 4725 of 2005. The risk class of your device sets the filing route, the documents and the review it goes through.
Risk classes
- Class I
- Class IIa
- Class IIb
- Class III
- Devices fall into four risk classes (I, IIa, IIb and III) under Decree 4725 of 2005.
- Health registrations are valid for 10 years.
- Filing is 100% online, through INVIMA's Virtual Office.
- Tecnovigilancia (post-market surveillance) obligations start after launch.
Chapter 5 of 6
Your route into Colombia, in four steps
- 01 · DiagnoseFree initial assessmentRisk class, applicable filing, timeline and fees for your device, before you commit.
- 02 · RegisterINVIMA health registrationDossier under Decree 4725, submission via INVIMA's Virtual Office, amendments, renewals, labeling and post-market surveillance.
- 03 · ProtectTrademarks, patents and IPFiling before the SIC and worldwide via Madrid Protocol and PCT, and defense against infringement and unfair competition.
- 04 · Operate & growLegal base and partnersCompany formation, contracts, compliance and data protection, plus distributor and importer search for Colombia and the region.
Chapter 6 of 6
Your partner: one point of contact, from dossier to resolution
- 1993
- founded in Bogotá
- +15,000
- permits, trademarks and patents
- +120
- countries via partners
- 1
- point of contact
Built for medical device companies. A Regulatory Affairs team specialized in medical devices, coordinating filings across Latin America.
What we handle
- Class I · IIa · IIb · III
- 10-year registration
- Tecnovigilancia
- +120 countries
Above all, their deep knowledge of INVIMA procedures. Second, their high level of organization and attention to detail.
Sources
- ProColombia, "Dispositivos médicos: Colombia tiene mercado y espacio para nueva inversión extranjera" (6 Oct 2026), citing sector analysis and DANE. Hourly wage data from Euromonitor.
- ProColombia, "Mercado farmacéutico colombiano abre espacio para nueva inversión extranjera en manufactura y biotecnología" (17 Mar 2026), citing DANE and Fitch Solutions/BMI.
- ProColombia, "Inversión y exportación: por qué Colombia interesa al capital global de dispositivos médicos" (2 Mar 2026), citing BMI.
Market values include estimates and forecasts from the cited sources.
Let's talk
Considering Colombia or Latin America?
Send us your device, your brand or your plan. We'll tell you which filing applies, how long it takes and what it costs. The first conversation is free.