Ecuador Product Registration Certification
Important Notes
- ARCSA Sanitary Registration: All pharmaceuticals, medical devices, cosmetics, foods, and dietary supplements require sanitary registration with the National Agency, and the certificate is mandatory for import and sale.
- Strict Regulation of Dietary Supplements as Food Category: These products are registered as foods. Ingredients, maximum limits, labeling, and claims must fully comply with Ecuadorian technical regulations, with strict claim review.
- Necessity of Local Importer or Legal Agent: Registration must be applied for by a locally registered Ecuadorian company, which becomes the registration holder.
- Spanish Documentation & Consular Legalization: All submitted documents must be in Spanish and require legalization by Ecuadorian diplomatic missions abroad.
- Government Pricing & Dominance of Public Procurement: Drug and some device prices are controlled. Centralized public procurement constitutes the major market share, with price being a decisive factor in tenders.
- Adherence to Andean Community Resolutions: As a CAN member, Ecuador actively adopts the bloc’s harmonized technical resolutions for medical devices, cosmetics, and foods.
Ecuador Specific Requirements
- Public Sector-Dominated Volume Market: The public health system is the largest single buyer of medicines and essential devices. Market access largely depends on successful participation in government tenders.
- Regulatory Environment in a Phase of Formalization: ARCSA is working to enhance its capacity and standardize processes. Companies may face uncertainties due to evolving rule interpretation and enforcement.
- Stability & Challenges from Dollarized Economy: The use of the US dollar eliminates exchange rate risk but can limit pricing flexibility in the face of imported inflation.
- Distribution Network Concentrated in Major Cities: Most commercial activity is centered in Quito and Guayaquil. Effective penetration into other provinces requires additional logistics and channel efforts.
- Active Participant in Regional Integration: Ecuador actively participates in CAN harmonization, making monitoring of CAN developments useful for anticipating national regulatory changes.
Medical Devices Registration
Regulatory Requirements
- ARCSA 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
- Andean Community Technical Regulations compliance
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Electrical safety certification (where applicable)
Main Process
- Product classification determination
- Technical documentation preparation
- ARCSA review submission
- Quality management system audit
- Registration certificate acquisition
Registration Timeline
7-14 months
Official Fees
USD 1,000 - 6,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
ARCSA
National Agency for Health Regulation, Control and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Ecuadorian 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 ARCSA and Andean Community guidelines
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports and performance data
Local Representative Appointment
Designate Ecuadorian Authorized Representative as required by ARCSA regulations
ARCSA Application Submission
Submit Medical Device Health Registration application with all supporting documentation
Post-Market Surveillance
Establish vigilance system and adverse event reporting requirements
Cosmetic Products Registration
Regulatory Requirements
- ARCSA Health Registration (Registro Sanitario)
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Andean Community Technical Regulations 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
- ARCSA registration submission
- GMP system establishment
- Technical documentation maintenance
Registration Timeline
3-7 months
Official Fees
USD 300 - 1,500
Service Fees
$4,500 - $12,000
Regulatory System Overview
ARCSA
National Agency for Health Regulation, Control and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Ecuadorian Ministry of Health, operating within Andean Community regulatory framework.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with ARCSA and Andean Community requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with ARCSA cosmetic regulations
Health Registration Submission
Submit Cosmetic Health Registration application to ARCSA
GMP System Implementation
Establish Good Manufacturing Practices quality system
Technical Documentation Maintenance
Maintain complete product technical file and compliance records
Health Supplements Registration
Regulatory Requirements
- ARCSA Health Registration (Registro Sanitario)
- 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
- Product formulation details
Main Process
- Product classification confirmation
- Technical documentation preparation
- ARCSA registration submission
- Scientific review assessment
- Registration certificate acquisition
Registration Timeline
5-9 months
Official Fees
USD 500 - 2,500
Service Fees
$6,000 - $16,000
Regulatory System Overview
ARCSA
National Agency for Health Regulation, Control and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Ecuadorian Ministry of Health, operating within Andean Community regulatory framework.
Health Supplements Registration Process
Regulatory Classification
Confirm product classification as health supplement under Ecuadorian regulatory framework
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and supporting documentation
Local Representative Appointment
Designate Ecuadorian Authorized Representative for regulatory submissions
ARCSA Registration Submission
Submit Health Supplement Registration application to ARCSA
Post-Market Compliance
Establish quality monitoring system and compliance framework