Venezuela Product Registration Certification
Important Notes
- INSA Regulation & Mandatory Registration: In law, pharmaceuticals, devices, cosmetics, foods, and dietary supplements require sanitary registration from the National Institute. In practice, processes are severely delayed due to administrative constraints.
- Nominal Regulation of Dietary Supplements under Food Laws: They are classified as foods. However, obtaining new registrations or renewals is extremely difficult, with high uncertainty in enforcement.
- Extreme Forex Controls & Import Licensing: All imports require complex and unpredictable forex and import license approvals, constituting the primary barrier to physical market entry.
- Local Company as Sole Application Route: Applications must be submitted through a locally registered company. The reliability and viability of such a partner is a paramount risk.
- Price Controls & Severe Economic Distortion: Strict price controls exist for essentials, but hyperinflation and shortages have led to a vast gap between official and parallel market prices, disrupting normal commerce.
- Historical Reference to Andean Community Regulations: The framework historically aligned with CAN, but regional harmonization has stalled, with ad-hoc national directives taking precedence.
Venezuela Specific Requirements
- High-Risk Market with Extreme Uncertainty: Market potential is severely constrained by the ongoing deep economic and humanitarian crisis. Any market entry must be considered a high-risk strategic venture.
- Essential Medicine Shortages & Irregular Supply Chains: Formal supply chains have broken down. Humanitarian aid and irregular channels are primary means of entry for some products.
- Severely Constrained Regulatory Function & Resources: Agencies like INSA face major operational challenges, rendering normal regulatory functions inefficient or stagnant.
- Deteriorated Business Environment & Heightened Compliance Risks: Operating with normal ethics and compliance standards is extraordinarily challenging, requiring top-level mitigation plans.
- Long-Term Reconstruction Potential vs. Current Operational Feasibility: While long-term need exists, predictable and scalable commercial operations are not feasible in the short to medium term. Extreme caution and non-commercial considerations are paramount.
Medical Devices Registration
Regulatory Requirements
- SACS Health Registration (Registro Sanitario)
- Risk-based classification system (Class I-IV)
- Technical documentation and test reports
- Spanish labeling and instructions for use
- Quality Management System compliance
- Local testing requirements
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Risk management documentation
Main Process
- Product classification determination
- Technical documentation preparation
- SACS review submission
- Local testing completion
- Registration certificate acquisition
Registration Timeline
10-18 months
Official Fees
VES 50,000 - 300,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
SACS
Autonomous Health Control Service (Servicio Autónomo de Contraloría Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Venezuelan Ministry of Health, operating under national health regulations.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-IV) according to Venezuelan regulations
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports and performance data
Local Representative Appointment
Designate Venezuelan Authorized Representative as required by SACS regulations
SACS Application Submission
Submit Medical Device Health Registration application with all supporting documentation
Local Testing Completion
Complete mandatory local testing in SACS-approved laboratories
Cosmetic Products Registration
Regulatory Requirements
- SACS Health Registration (Registro Sanitario)
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Local ingredient testing requirements
- 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
- SACS registration submission
- Local testing completion
- Technical documentation maintenance
Registration Timeline
6-12 months
Official Fees
VES 10,000 - 80,000
Service Fees
$6,000 - $16,000
Regulatory System Overview
SACS
Autonomous Health Control Service (Servicio Autónomo de Contraloría Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Venezuelan Ministry of Health, operating under national health regulations.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with Venezuelan requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with SACS cosmetic regulations including claims
Health Registration Submission
Submit Cosmetic Health Registration application to SACS
Local Testing Completion
Complete mandatory product testing in approved laboratories
GMP System Implementation
Establish Good Manufacturing Practices quality system
Health Supplements Registration
Regulatory Requirements
- SACS Health Registration (Registro Sanitario)
- Ingredient safety and efficacy evidence
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Local testing and evaluation requirements
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Product formulation details
Main Process
- Product classification confirmation
- Technical documentation preparation
- SACS registration submission
- Local testing completion
- Registration certificate acquisition
Registration Timeline
8-14 months
Official Fees
VES 20,000 - 120,000
Service Fees
$8,000 - $20,000
Regulatory System Overview
SACS
Autonomous Health Control Service (Servicio Autónomo de Contraloría Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Venezuelan Ministry of Health, operating under national health regulations.
Health Supplements Registration Process
Regulatory Classification
Confirm product classification as health supplement under Venezuelan regulatory framework
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and supporting documentation
Local Representative Appointment
Designate Venezuelan Authorized Representative for regulatory submissions
SACS Registration Submission
Submit Health Supplement Registration application to SACS
Local Assessment Completion
Complete local testing and quality assessment in approved laboratories