INVIMA

The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) is Colombia's national regulatory authority responsible for ensuring the safety, efficacy, and quality of medicines, medical devices, food products, cosmetics, and other health-related products. Operating under the Ministry of Health and Social Protection, INVIMA plays a critical role in protecting public health through pre-market authorization, post-market surveillance, and enforcement.

Role and responsibilities:

INVIMA's core functions include:
- Pre-market evaluation and sanitary registration of medical devices
- Inspection and surveillance of manufacturers, importers, and distributors
- Post-market monitoring and pharmacovigilance
- Control of imports and exports of regulated products
- Investigation of adverse events and product complaints
- Issuance of safety alerts and product recalls
- Licensing of establishments handling regulated products
- Development of technical standards and regulations
- Consumer protection and public education

Legal framework:

INVIMA operates under Colombian health legislation:
- Decree 4725 of 2005 - Regulates sanitary registration and surveillance of medical devices
- Resolution 4002 of 2007 - Establishes requirements for medical device registration
- Resolution 5227 of 2014 - Updates medical device registration procedures
- Law 1164 of 2007 - Human resources in health
- Additional resolutions and decrees for specific device categories

Medical device classification:

INVIMA classifies medical devices based on risk level, similar to international frameworks:

Class I - Low risk:
- Minimal potential harm to user or patient
- Examples: Bandages, examination gloves, hospital beds
- Simplified registration pathway
- Lower fees and shorter review times

Class IIa - Low-medium risk:
- Moderate potential risk
- Examples: Syringes, blood pressure monitors, dental instruments
- Standard registration requirements
- Technical documentation required

Class IIb - Medium-high risk:
- Increased risk potential
- Examples: Ventilators, X-ray equipment, dialysis machines
- More rigorous evaluation
- Clinical evidence may be required

Class III - High risk:
- Highest risk to patient safety
- Examples: Heart valves, implantable defibrillators, drug-eluting stents
- Most stringent regulatory scrutiny
- Comprehensive clinical evidence mandatory
- Longest review timelines

Sanitary registration process:

All medical devices must obtain Sanitary Registration (Registro Sanitario) before being marketed in Colombia:

Step 1: Preparation and documentation:
Manufacturers or importers must compile:
- Application form (Formulario Único de Dispositivos Médicos)
- Certificate of Free Sale from country of origin
- Quality Management System certificate (ISO 13485 or equivalent)
- Technical documentation including:
- Device description and specifications
- Intended use and indications
- Manufacturing information
- Labeling and instructions for use (Spanish translation required)
- Risk analysis documentation
- Clinical evidence (for higher risk classes)
- Certificate of Good Manufacturing Practices (if applicable)
- Power of attorney if using representative

Step 2: Local representative requirement:

Colombian Regulatory Holder (Titular del Registro Sanitario):
- Foreign manufacturers must appoint Colombian legal representative
- Holder must be registered in Colombia (company or individual)
- Responsible for regulatory compliance and communication with INVIMA
- Maintains technical documentation in Colombia
- Liaison for post-market surveillance and adverse event reporting

Step 3: Submission:
- Submit application through INVIMA's online platform (SIVICOS - Sistema de Información de Vigilancia y Control Sanitario)
- Pay applicable registration fees (vary by device class and type)
- Include all required documentation in Spanish
- INVIMA assigns tracking number

Step 4: INVIMA review:
- Administrative completeness check
- Technical evaluation by INVIMA specialists
- Assessment of safety, efficacy, and quality
- Review timelines vary by class:
- Class I: Typically 30-60 days
- Class IIa: Typically 60-90 days
- Class IIb: Typically 90-120 days
- Class III: 120+ days
- INVIMA may request additional information (información adicional)

Step 5: Resolution and registration:
- Upon approval, INVIMA issues Resolution granting Sanitary Registration
- Registration number (e.g., INVIMA 2024DM-xxxxxxx)
- Registration valid for 10 years
- Renewable before expiration
- Registered devices included in INVIMA public database

Documentation requirements:

Certificate of Free Sale:
- Issued by competent authority in country of manufacture
- Confirms device is legally marketed in that country
- Must be apostilled or legalized
- Translation to Spanish required

ISO 13485 certification:
- Quality Management System certification required
- Issued by accredited certification body
- Demonstrates manufacturing quality controls
- Valid and current certificate required

Labeling and instructions:
- All labeling must be in Spanish
- Includes device name, intended use, manufacturer information
- Instructions for use with warnings and precautions
- Compliance with Colombian labeling regulations

Clinical evidence:
- For Class IIb and III devices, clinical data required
- Can include:
- Clinical investigation reports
- Literature reviews
- Post-market clinical follow-up data
- Equivalence to predicate devices (when applicable)

Post-market requirements:

Pharmacovigilance and adverse event reporting:
- Mandatory reporting of adverse events and incidents
- Serious incidents reported within 10 working days
- Non-serious events in periodic reports
- INVIMA investigates and may require corrective actions

Quality Management System maintenance:
- Manufacturers must maintain GMP compliance
- Subject to INVIMA inspections
- Non-compliance can result in suspension of registration

Recalls and safety actions:
- Holders must notify INVIMA of recalls or field corrective actions
- INVIMA may order recalls for safety reasons
- Public communication required for serious safety issues

Post-market surveillance:
- Ongoing monitoring of device performance
- Collection and analysis of real-world data
- Renewal applications must include post-market evidence

Modifications and changes:

Registration modifications:
Changes to registered device may require amendment to registration:
- Minor changes - Notification to INVIMA (e.g., address change)
- Moderate changes - Modified registration application (e.g., labeling updates)
- Major changes - New registration required (e.g., significant design changes, new intended use)

Transfer of registration:
Registration can be transferred between holders with INVIMA approval and proper documentation.

Renewal:
Registrations valid for 10 years, renewable by submitting:
- Renewal application
- Updated technical documentation
- Post-market surveillance summary
- Current ISO 13485 certificate
- Updated Certificate of Free Sale

Import and distribution:

Import permits:
- Importers must have Sanitary Registration for each device
- Import documentation includes invoice, packing list, Certificate of Origin
- Customs clearance requires INVIMA registration number
- INVIMA may inspect imported shipments

Distribution licensing:
- Distributors and retailers require licenses from INVIMA
- Compliance with storage and handling requirements
- Traceability through supply chain

In Vitro Diagnostics (IVD):

IVD products have specific requirements:
- Separate classification and registration pathway
- Risk-based classification (Class I, II, III for IVDs)
- Performance evaluation requirements
- Lot release requirements for certain IVDs

Special device categories:

Active implantable devices:
- Rigorous clinical evidence requirements
- Specific manufacturing controls
- Enhanced post-market surveillance

Radiation-emitting devices:
- Additional radiation safety documentation
- Compliance with international radiation safety standards
- Specialized review process

Software as Medical Device (SaMD):
- Increasing regulatory attention
- Software lifecycle documentation
- Cybersecurity considerations
- Validation and verification evidence

Fees:

INVIMA charges fees based on device classification:
- Class I: Lower fees
- Class IIa, IIb, III: Progressively higher fees
- Renewal fees (typically lower than initial registration)
- Modification fees
- Annual surveillance fees in some cases

Fees are subject to change and published in official INVIMA fee schedules.

Challenges and considerations:

Spanish language requirement:
All documentation, labeling, and instructions must be in Spanish, requiring professional translation.

Local representative identification:
Finding qualified and reliable Colombian Regulatory Holder is essential.

Registration timelines:
Delays can occur if documentation is incomplete or additional information requested.

Regulatory updates:
INVIMA periodically updates regulations; staying current is important.

Post-market compliance:
Ongoing vigilance and quality system maintenance required throughout registration validity.

Regional harmonization:

Colombia participates in regional harmonization efforts:
- PAHO (Pan American Health Organization) collaboration
- Alignment with IMDRF (International Medical Device Regulators Forum) principles
- Recognition of international standards (ISO 13485, ISO 14971)
- Efforts toward mutual recognition with neighboring countries

INVIMA continues to strengthen its regulatory framework, balancing patient safety with facilitating access to innovative medical technologies in Colombia.