INVIMA — Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos — is the gate every sponsor running a first-in-human or pivotal study in Colombia has to walk through. Get the dossier right and you’re on-site in ~90 business days. Get it wrong and you’re re-filing at day 120 with a fresh evaluation clock.
This guide is the exact checklist bioaccess® uses internally, updated for the 2024 medical-device framework revisions and the 2026 UVT fee schedule.
What INVIMA is and what it regulates
INVIMA is Colombia’s national health authority for medicines, medical devices, biologics, and food. Clinical trial authority sits primarily under three legal instruments:
- Resolución 2378/2008 — the Good Clinical Practice framework and core CTA requirements.
- Decreto 677/1995 — the drug regulatory foundation, still governing pharmaceutical CTAs.
- Decreto 4725/2005 + 2024 medical-device framework revisions — the device pathway, including the risk classification matrix.
Submission pathway by product class
The dossier depth, evaluation timeline, and CEI review depth all scale with product class:
| Product | Pathway | Typical INVIMA timeline |
|---|---|---|
| Class I / IIa devices | Streamlined CTA | 60–85 business days |
| Class IIb / III devices | Full CTA + expert panel review | 90–120 business days |
| Drugs (small molecule) | CTA under Decreto 677 | 90–110 business days |
| Biologics / ATMPs | CTA + INVIMA biologics unit | 110–150 business days |
| Combination products | Dual-track (drug + device) | 120–160 business days |
The dossier: 14 required modules
- Cover letter and INVIMA form signed by the sponsor’s Colombian legal representative.
- Protocol (English + Spanish executive summary, minimum).
- Investigator’s Brochure dated within the last 12 months.
- IMPD or device-equivalent technical dossier — for devices, this is the ISO 14155 + ISO 13485 evidence package.
- GMP certificate for the manufacturing site (CE, FDA, ANVISA, or PIC/S accepted).
- Sponsor legal representative appointment — must be a Colombian entity or resident.
- Clinical trial insurance certificate — mandatory local policy, minimum coverage per Resolución 2378.
- Informed consent form in Spanish (and any Indigenous-language variants required by the study population).
- Investigator CVs + Colombian medical licenses for every named PI and sub-investigator.
- Study budget and financial disclosure per Colombian requirements.
- Contracts — CTA with sites, service agreements with the CRO, laboratory agreements.
- Certified Spanish translations of all patient-facing materials.
- Apostilled documents for foreign-origin certificates (GMP, incorporation, etc.).
- CEI approval or filing evidence — filing in parallel is expected; final approval before FPI.
Timelines: what actually happens between filing and site activation
- Pre-submission meeting (optional but recommended): 15–25 days to schedule, resolves classification and pathway questions.
- Formal filing: Case number issued within 5 business days.
- Evaluation: 70–100 business days for devices, 90–110 for drugs (median).
- Auto de requerimientos (deficiency letter, if any): 20 business days to respond, resets a partial clock.
- Conditional approval: Sites can begin activation (contracts, staff training, EDC build).
- Final approval: Enrollment permitted after CEI approval is on file.
Fees: the 2026 UVT-based schedule
INVIMA fees are indexed to the Unidad de Valor Tributario (UVT), which is revised annually. For 2026, a device CTA evaluation runs approximately 45–95 UVT depending on class, and a drug CTA runs 60–130 UVT. Amendment fees are 15–35 UVT each. Payments are made via PSE or bank transfer against the case number; INVIMA will not open evaluation until the fee is confirmed.
Ethics Committee (CEI) parallel review
The single highest-leverage optimization in INVIMA submissions is running CEI review in parallel, not sequentially. INVIMA does not require CEI approval to open evaluation — it only requires it before final authorization to enroll.
Practical model: file the INVIMA dossier and the CEI dossier the same week. CEI review typically closes in 30–45 days first pass, well inside INVIMA’s 70–100 day evaluation window. By the time INVIMA issues final approval, CEI approval is already on file and site activation can begin immediately.
Top 8 reasons INVIMA rejects or issues auto de requerimientos
- Missing or expired GMP certificate for the investigational product manufacturing site.
- Sponsor legal representative not properly constituted under Colombian law (must have local address and registered NIT).
- Insurance policy from a non-Colombian carrier without local endorsement.
- Protocol version mismatch between the dossier, the ICF, and the CEI submission.
- Investigator CVs missing Colombian medical license numbers or with expired credentials.
- Untranslated or machine-translated Spanish documents — CEIs and INVIMA both flag this.
- Risk classification errors — sponsors defaulting to Class IIa when the device is IIb.
- Incomplete preclinical package — missing biocompatibility (ISO 10993), sterilization validation, or shelf-life data.
Post-approval obligations
- Amendments: Substantial amendments filed as separate cases; typical review 30–60 business days.
- SAE reporting: Within 15 calendar days for non-fatal, 7 days for fatal or life-threatening.
- Annual reports: Study status, enrollment, safety summary, and CEI continuing-review evidence.
- Close-out: Final report + database lock evidence + CEI close-out within 12 months of last patient last visit.
How bioaccess® manages INVIMA submissions end-to-end
bioaccess® has managed 40+ INVIMA CTAs across MedTech, Biopharma, and Radiopharma programs over the last five years. Median approval time on the last twelve submissions: 74 business days. Zero rejections at first review over the same window; three received auto de requerimientos and were re-approved inside 20 days.
The operating model: dossier assembly with a Colombia-based regulatory lead, parallel CEI filing at day 0–7, insurance and legal-rep binding pre-filing, and a named PM accountable end-to-end. Global Trial Accelerators™ lets sponsors run INVIMA in parallel with ANMAT, ANVISA, COFEPRIS, and MINSA Panama filings under a single accountable operating team.
For a scoped INVIMA feasibility call, contact bioaccess®.
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