Colombia Product Registration Certification
Important Notes
- INVIMA Sanitary Registration/Notification: All pharmaceuticals, medical devices, cosmetics, foods, and dietary supplements require sanitary registration or notification with the National Institute and a corresponding sanitary registration certificate.
- Specific Regulation of Dietary Supplements under Food Framework: These products are classified as foods under specific resolutions. Ingredients and maximum dosages are on positive lists, and all health claims require pre-authorization from INVIMA.
- Mandatory Role of Local Authorized Representative: A foreign manufacturer must appoint a locally registered Colombian company as its Authorized Representative, who is the applicant and legal responsible entity.
- Spanish Documentation & Andean Community Compliance: All documents must be in Spanish. As a CAN member, Colombia’s technical regulations are largely aligned with the bloc’s harmonized resolutions.
- Price Control & Reimbursement Listing Negotiation: Drug prices are regulated. Inclusion in the mandatory health plan reimbursement lists is crucial and involves complex negotiations.
- Accelerated Pathways for Innovative Products: INVIMA has established priority and accelerated review channels for innovative drugs and devices with significant therapeutic advantages.
Colombia Specific Requirements
- Vibrant & Fast-Growing Core Andean Market: With a large population and growing healthcare expenditure, the market is dynamic and receptive to new products, making it a regional priority.
- Universal Health Insurance System as Market Driver: The comprehensive health insurance system is the primary payer and shapes the market through its reimbursement policies and clinical guidelines.
- Leader in Regulatory Modernization & Digitalization: INVIMA is a regional leader in modernization, widely adopting electronic submissions and certificates, enhancing transparency and communication efficiency.
- Growing Emphasis on Local Evidence & HTA: For innovative products seeking reimbursement, providing clinical and pharmacoeconomic data relevant to the local context is increasingly important.
- Mix of Concentrated & Diverse Channels: The market is dominated by large distribution groups but also features extensive pharmacy chains and independents, requiring tailored channel strategies.
Medical Devices Registration
Regulatory Requirements
- INVIMA Registration Certification
- Risk-based classification system (Class I-IV) according to Resolution 4816/2008
- Technical documentation and test reports
- Spanish labeling and instructions for use
- Quality Management System certification
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Electrical safety certification (where applicable)
- Risk management documentation
Main Process
- Product classification determination
- Technical documentation preparation
- INVIMA review submission
- Quality management system audit
- Registration certificate acquisition
Registration Timeline
8-18 months
Official Fees
COP 2,000,000 - 12,000,000
Service Fees
$12,000 - $32,000
Regulatory System Overview
INVIMA
National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
Responsible for medical devices, cosmetics, complementary foods, pharmaceutical products, and food product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Colombian Ministry of Health, operating within Andean Community regulatory framework.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-IV) according to Colombian INVIMA regulations
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports and performance data
Local Representative Appointment
Designate Colombian Authorized Representative as required by INVIMA regulations
INVIMA Application Submission
Submit Medical Device Registration application with all supporting documentation
Post-Market Surveillance
Establish vigilance system and adverse event reporting requirements
Cosmetic Products Registration
Regulatory Requirements
- Cosmetic Health Notification
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Restricted ingredients and claims compliance
- Product safety data and toxicological information
- Microbiological quality specifications
- Stability study documentation
- Manufacturing process description
- Quality control procedures
Main Process
- Ingredient formulation assessment
- Label review preparation
- INVIMA notification submission
- GMP system establishment
- Technical documentation maintenance
Registration Timeline
3-7 months
Official Fees
COP 500,000 - 2,500,000
Service Fees
$5,000 - $14,000
Regulatory System Overview
INVIMA
National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
Responsible for medical devices, cosmetics, complementary foods, pharmaceutical products, and food product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Colombian Ministry of Health, operating within Andean Community regulatory framework.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with Colombian INVIMA requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with INVIMA cosmetic regulations
Health Notification Submission
Submit Cosmetic Health Notification application to INVIMA
GMP System Implementation
Establish Good Manufacturing Practices quality system
Technical Documentation Maintenance
Maintain complete product technical file and compliance records
Complementary Foods Registration
Regulatory Requirements
- INVIMA Registration Approval
- Ingredient safety and efficacy evidence
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Scientific basis for health claims
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Nutritional information and composition
Main Process
- Product classification confirmation
- Technical documentation preparation
- INVIMA registration submission
- Scientific review assessment
- Registration certificate acquisition
Registration Timeline
6-14 months
Official Fees
COP 1,500,000 - 6,000,000
Service Fees
$8,000 - $20,000
Regulatory System Overview
INVIMA
National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
Responsible for medical devices, cosmetics, complementary foods, pharmaceutical products, and food product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Colombian Ministry of Health, operating within Andean Community regulatory framework.
Complementary Foods Registration Process
Regulatory Classification
Confirm product classification as complementary food under Colombian regulatory framework
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and supporting documentation
Local Representative Appointment
Designate Colombian Authorized Representative for regulatory submissions
INVIMA Registration Submission
Submit Complementary Food Registration application to INVIMA
Post-Market Compliance
Establish quality monitoring system and compliance framework