General information, not legal or regulatory advice. Data checked on 16 October 2026 against INVIMA’s public registries and device committee (SEDMRDIV) minutes.
Colombia has strong hospitals and investigators, but getting a device clinical study through INVIMA’s Specialized Chamber for Medical Devices (Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro, SEDMRDIV) has become harder. Here is what INVIMA’s own records show.
Approvals by year
| Year | Approved | Not approved |
|---|---|---|
| 2021 | 5 | 3 |
| 2022 | 4 | 1 |
| 2023 | 3 | 6 |
| 2024 | 3 (all January to June) | 3 |
| 2025 (to October) | 0 | 5 |
| 2026 | No actas or registry update published | |
Sources: INVIMA registry of approved device studies, 2021 to October 2025; registry of studies not approved; actas index.
Key facts
- Last approval: Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. Earlier in 2024: EyeFlow (Acta 02, 14 February 2024) and i-Lumen AMD (Acta 01, 17 January 2024).
- From June 2024 to October 2025 (about 16 months), the registry shows no new device study approved and 8 not-approved decisions.
- 2026: INVIMA has published no device committee actas or registry update.
- Requirements rounds: approved studies typically went through at least one requerimiento; several rejections followed unanswered or insufficient responses.
What it means for sponsors
Plan a Colombian device study with a realistic clock, a complete dossier, and capacity to answer detailed INVIMA requirements. Many sponsors pair Colombia with a faster-starting country. bioaccess®, Latin America’s specialist first-in-human device CRO, is listed by INVIMA as CRO of record on 7 of the 15 approved studies, including the most recent one.
Frequently asked questions
How many device clinical studies did INVIMA approve from 2021 to 2025?
INVIMA’s registry lists 15 device clinical studies approved from 2021 to October 2025: 5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October.
When did INVIMA last approve a new device study?
The most recent approval in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13.
Has INVIMA published 2026 device committee minutes?
No. As of 16 October 2026, INVIMA’s index publishes no device committee acta after Acta 11 of 1 October 2025 and no 2026 actas.
How long does INVIMA device approval take?
Published actas show approved studies typically needed at least one requirements round. Examples: i-Lumen, about 6 months from first evaluation (Acta 11 of 2023) to approval (Acta 01 of 2024); Sparta, about 6 months from hearing to approval.
Related pages
- INVIMA clinical trial submission checklist
- Clinical trials in Colombia
- CRO in Colombia
- First-in-human trials in Colombia
- INVIMA clinical trial approval process
- Clinical trial cost in Colombia
Next step
Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.