Colombia Medical Device Registration (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
1. Regulatory Authority & Framework
Medical devices in Colombia are regulated under:
- Decree 4725 of 2005 (core medical device regulation)
- Decree 677 of 1995 (general sanitary registration)
- Resolution 4002 of 2007 (classification rules)
- Resolution 4816 of 2008 (technical dossier)
- Resolution 2190 of 2019 (reliance pathway updates)
Authority:
INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Key characteristics:
- One of LATAM’s fastest and most predictable regulatory systems
- Strong reliance pathways based on FDA/CE/Health Canada approvals
- Registration validity: 10 years (very favorable)
2. Device Classification (Class I / IIa / IIb / III)
Colombia follows a 4-class system aligned with EU MDR/GHTF:
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low | Non-sterile consumables |
| Class IIa | Low–Moderate | Suction pumps, reusable devices |
| Class IIb | Moderate | Blood glucose meters, HF surgical devices |
| Class III | High | Ventilators, implants, robotic systems |
Classification based on:
- Intended use
- Invasiveness
- Duration of contact
- Active/implantable nature
3. Registration Pathways in Colombia
INVIMA offers three main pathways, similar to Mexico:
3.1 Standard Registration (Full Review)
For devices without approvals from reference agencies.
Requirements:
- Complete technical dossier
- QMS documentation
- Testing reports
- Clinical evaluation for Class IIb/III
- Spanish labeling
Timeline: 6–12 months
3.2 Special Registration / Reliance Pathway (Fast Track)
Applicable when device is approved by:
- FDA (510k / PMA)
- EU CE Certificate (MDR/MDD)
- Health Canada licence
- Australia TGA approval
- Japan MHLW/PMDA
Benefits:
- Major reduction in dossier requirements
- Faster approval
- No local testing required
Timeline: 1–3 months (typical)
This is the preferred route for most global manufacturers.
3.3 Registration by Manufacturer Conformity (Very Fast)
For Class I & IIa devices only:
- Reliance on manufacturer declaration
- Minimal documentation
- Auto-approval in many cases
Timeline: 1–2 months
4. Local Legal Representative Requirement
Foreign manufacturers must appoint a Local Authorized Representative (LAR) or Legal Representative in Colombia.
LAR responsibilities:
- Owns certificate
- Communicates with INVIMA
- Manages PMS, vigilance, and recalls
- Manages renewals, variations
- Appears on labeling
Choosing a strong LAR is important to avoid regulatory lock-in (similar to Brazil’s BRH).
5. Dossier Requirements (Technical File)
Colombia uses a hybrid system similar to EU MDR + LATAM requirements.
Administrative Documents
- Application form
- Legal Representative authorization
- Free Sale Certificate (apostilled)
- ISO 13485 (or equivalent QMS)
- Power of Attorney
- Device description & model list
Technical Evidence
- Risk management (ISO 14971)
- Biocompatibility
- Sterilization validation (if sterile)
- Electrical safety & EMC (IEC 60601)
- Software documentation (IEC 62304, cybersecurity)
- Performance testing
- Clinical evaluation (Class IIb & III)
- Labeling in Spanish
For reliance route, much of the above is replaced by CE/FDA documentation.
6. Fees & Timelines
Government Fees (Typical)
- Class I: ~USD 300–500
- Class IIa: ~USD 500–700
- Class IIb: ~USD 700–1,000
- Class III: ~USD 1,000–1,500
Timelines
| Pathway | Timeline |
|---|---|
| Class I/IIa – Conformity Registration | 1–2 months |
| Reliance (FDA/CE/TGA/HC) | 1–3 months |
| Standard Review | 6–12 months |
Registration validity: 10 years.
7. Labeling Requirements
Labeling must be in Spanish and include:
- Device name/model
- Manufacturer & local representative
- Country of origin
- Storage/handling instructions
- Warnings/precautions
- Lot/serial number
- IFU in Spanish
- INVIMA registration number (post-approval)
8. Importation Requirements
Once registered:
- Importer must have INVIMA Import Authorization
- Customs clearance via DIAN
- Spanish labeling enforced at customs (stickers acceptable)
- Consistency between product, labeling, and INVIMA certificate is verified
9. Post-Market Surveillance
Mandatory requirements:
- Adverse event reporting
- Field safety corrective actions (FSCA)
- Periodic updates
- Renewals (every 10 years)
- Variations and amendments
- Traceability for high-risk devices
10. Consulting Notes for Your Device Portfolio
| Device Type | Class | Colombia Notes |
|---|---|---|
| Soft contact lenses | IIb / III | Clinical evidence + biocompatibility; reliance route recommended |
| Surgical robots / AR–MR navigation (SyngAR™) | Class III | High scrutiny; strong software validation; reliance route reduces burden |
| High-frequency electrosurgical devices | Class IIb / III | Must meet IEC 60601-2-2; reliance route highly recommended |
| Blood glucose meters & strips | Class IIb | ISO 15197 performance accepted; reliance speeds approval |
| Single-use serum preparation devices | Class IIa / IIb | Sterilization validation required; reliance possible |
11. Advantages of the Colombia Market
- Very fast approvals through reliance (1–3 months)
- Recognizes FDA, CE, TGA, Health Canada approvals
- Long certificate validity (10 years)
- Predictable and transparent regulatory processes
- Strategic entry point for the Andean region & LATAM