Guatemala Product Registration & Certification
Important Notes
- All technical documentation, labeling, and instructions must be in Spanish
- Medical devices, cosmetics, and pharmaceuticals must obtain health registration certificate for market distribution
- Must appoint authorized representative in Guatemala responsible for registration affairs
- Products must comply with Central American Technical Regulations (RTCA) requirements
- Health registration certificates are typically valid for 5 years and require periodic renewal
- Post-market surveillance and adverse event reporting systems must be established after registration
Guatemala specific Requirements
- Guatemala implements strict Spanish language labeling and documentation system
- All technical documentation must be in Spanish with certified translation
- Regulatory system follows Central American Technical Regulations (RTCA) unified requirements
- Medical devices follow I-III risk classification system
- Must conduct registration applications through authorized representatives in Guatemala
- Emphasis on quality system certification and good manufacturing practice compliance
- Health registration certificates implement validity period management system requiring periodic renewal
Medical Devices Registration
Regulatory Requirements
- Medical Device Health Registration (Registro Sanitario)
- Classification Management per Central American Technical Regulations (RTCA) (Class I, II, III)
- Complete Spanish Technical Documentation
- Quality Management System Certificate (ISO 13485)
- Free Sale Certificate from Country of Origin
- Product Performance Test Reports
- Biocompatibility Test Reports (if applicable)
- Electrical Safety Certification (if applicable)
- Declaration of Conformity
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Representative Appointment
- MSPAS Registration Application
- Technical Review Approval
- Registration Certificate Acquisition
Registration Timeline
6-12 months
Official Fees
$700 - $5,000
Service Fees
$8,000 - $22,000
Regulatory System Overview
MSPAS
Ministry of Public Health and Social Assistance Guatemala
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 Guatemala.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
SAT
Superintendence of Tax Administration Guatemala
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 (RTCA) (Class I-III)
Technical Documentation Preparation
Prepare complete Spanish technical documentation including product specifications, test reports, quality system certificates
Local Representative Appointment
Appoint authorized representative in Guatemala responsible for registration and regulatory affairs
Registration Application Submission
Submit medical device health registration application to MSPAS
Technical Review
Pass MSPAS technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Health Registration Certificate (Registro Sanitario)
- Ingredient Safety Assessment Report (Spanish)
- Spanish Product Information File
- Good Manufacturing Practice Certification
- Product Stability Data
- Microbiological Test Reports
- Labeling Compliance Proof
- Prohibited Ingredients Compliance Declaration
Main Process
- Ingredient Formulation Assessment
- Safety Documentation Preparation
- Local Representative Appointment
- Health Registration Application
- Labeling Compliance Review
Registration Timeline
4-7 months
Official Fees
$500 - $2,500
Service Fees
$6,000 - $15,000
Regulatory System Overview
MSPAS
Ministry of Public Health and Social Assistance Guatemala
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 Guatemala.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
SAT
Superintendence of Tax Administration Guatemala
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Cosmetics Registration Process
Ingredient Formulation Assessment
Verify all ingredients comply with Central American cosmetic regulations permitted and restricted lists
Safety Documentation Preparation
Prepare complete Spanish safety assessment report and technical documentation
Local Representative Appointment
Appoint authorized representative in Guatemala responsible for registration affairs
Health Registration Application
Submit cosmetic health registration application and related technical documents to MSPAS
Labeling Compliance Review
Ensure product labeling fully complies with Guatemala cosmetic labeling regulations
Pharmaceuticals Registration
Regulatory Requirements
- Pharmaceutical Health Registration Certificate (Registro Sanitario)
- Complete Technical Registration Dossier (Spanish)
- Quality, Safety, and Efficacy Data
- Stability Study Data (ICH Guidelines)
- 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
9-18 months
Official Fees
$1,200 - $7,000
Service Fees
$16,000 - $38,000
Regulatory System Overview
MSPAS
Ministry of Public Health and Social Assistance Guatemala
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 Guatemala.
Dirección de Regulación
Directorate of Health Product Regulation
Responsible for technical evaluation, registration approval, and regulatory compliance supervision of health products
SAT
Superintendence of Tax Administration Guatemala
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 Spanish technical registration dossier and supporting documents
Local Representative Appointment
Appoint authorized representative in Guatemala with appropriate qualifications
Health Registration Application
Submit pharmaceutical health registration application to MSPAS
Technical Review Coordination
Coordinate with MSPAS to complete technical review, question responses and supplementary data submission