Costa Rica Product Registration & Certification
Important Notes
- Mandatory Spanish Requirements: All technical documents, labels and instructions must be in Spanish requiring certified translation
- Ministry of Health Registration System: Medical devices, cosmetics, pharmaceuticals must obtain Ministry of Health registration certificates
- Legal Representative Responsibility: Must appoint Costa Rican authorized representative for registration affairs
- RTCA Technical Regulations: Products must comply with Central American Technical Regulations (RTCA) requirements
- Registration Validity Management: Health registration certificates valid for 5 years requiring renewal application 6 months in advance
- Document Authentication Process: Free sale certificates require origin country notarization, foreign ministry legalization and consular authentication
- Post-market Surveillance Obligations: Must establish post-market surveillance and adverse event reporting system
Mexico specific Requirements
- Strict Spanish Language System: All technical documents and labels must be in Spanish
- Central American Regulation Dominance: Regulatory system strictly follows Central American Technical Regulations (RTCA)
- Medical Device Four-class Classification: Adopts Class I, IIa, IIb, III risk classification system
- Pharmaceutical CTD Format Requirements: Pharmaceutical registration requires complete Common Technical Document format
- Mandatory Authorized Representative System: Must register through Costa Rican authorized representative
- Regional Regulatory Coordination: As core member of Central American integration system, advances regional coordination
- High-standard Healthcare System: Maintains Central America's most developed healthcare system with higher quality requirements
Medical Devices Registration
Regulatory Requirements
- Medical Device Health Registration Certificate (Registro Sanitario de Dispositivos Médicos)
- Classification Management by Risk Level (Class I, IIa, IIb, III)
- Complete Spanish Technical Documentation
- Quality Management System Certificate (ISO 13485)
- Free Sale Certificate from Country of Origin (with apostille)
- Product Performance Test Reports
- Biocompatibility Test Reports (if applicable)
- Electrical Safety Certification (if applicable)
- Clinical Evaluation Report (Class IIb, III devices)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Representative Appointment
- Ministry of Health Application Submission
- Technical Review
- Health Registration Certificate Acquisition
Registration Timeline
6-12 months
Official Fees
$800 - $6,000
Service Fees
$10,000 - $28,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health of Costa Rica
Comprehensively responsible for health registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, and pharmaceuticals. Serves as the supreme health product regulatory authority in Costa Rica.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
Dirección de Aduanas
General Directorate of Customs
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to Central American Technical Regulations (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete Spanish technical documentation including product specifications, test reports, quality system certificates
Local Representative Appointment
Appoint authorized representative in Costa Rica responsible for registration and regulatory affairs
Ministry of Health Application
Submit medical device health registration application to Costa Rica Ministry of Health
Technical Review
Pass Ministry technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Health Registration Certificate (Registro Sanitario de Productos Cosméticos)
- Ingredient Safety Assessment Report (Spanish)
- Spanish Product Information File
- Good Manufacturing Practice Certification
- Product Stability Data
- Microbiological Test Reports
- Labeling Compliance Proof
- Prohibited and Restricted Ingredients Compliance Declaration
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Local Representative Appointment
- Health Registration Application
- Labeling Compliance Review
Registration Timeline
4-8 months
Official Fees
$600 - $3,000
Service Fees
$7,000 - $18,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health of Costa Rica
Comprehensively responsible for health registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, and pharmaceuticals. Serves as the supreme health product regulatory authority in Costa Rica.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
Dirección de Aduanas
General Directorate of Customs
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Central American cosmetic regulations permitted and restricted lists
Safety Assessment Report
Prepare Spanish product safety assessment report signed by qualified safety assessor
Local Representative Appointment
Appoint authorized representative in Costa Rica responsible for registration affairs
Health Registration Application
Submit cosmetic health registration application and related technical documents to Ministry of Health
Labeling Compliance Review
Ensure product labeling fully complies with Costa Rica cosmetic labeling regulations
Pharmaceuticals Registration
Regulatory Requirements
- Pharmaceutical Health Registration Certificate (Registro Sanitario de Medicamentos)
- Complete CTD Format Technical Dossier (Modules 1-5)
- Quality, Safety, and Efficacy Data
- Stability Study Data (ICH Climatic Zone IVB)
- Good Manufacturing Practice Certification
- Registration Certificate from Country of Origin
- Analytical Methods and Validation Data
- Bioequivalence Studies (for generic drugs)
Main Process
- Product Classification Confirmation
- Registration Dossier Preparation
- Local Representative Appointment
- Health Registration Application
- Technical Review Coordination
Registration Timeline
12-24 months
Official Fees
$2,000 - $10,000
Service Fees
$20,000 - $50,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health of Costa Rica
Comprehensively responsible for health registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, and pharmaceuticals. Serves as the supreme health product regulatory authority in Costa Rica.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
Dirección de Aduanas
General Directorate of Customs
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Pharmaceuticals Registration Process
Product Classification Confirmation
Confirm product falls under pharmaceutical regulatory category, determine applicable registration classification
Registration Dossier Preparation
Prepare complete CTD format Spanish technical dossier and supporting documents
Local Representative Appointment
Appoint authorized representative in Costa Rica with appropriate qualifications
Health Registration Application
Submit pharmaceutical health registration application to Ministry of Health
Technical Review Coordination
Coordinate with Ministry to complete technical review, question responses and supplementary data submission