Panama 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 Panama responsible for registration affairs
- Health registration certificates are typically valid for 5 years and require periodic renewal
- Pharmaceutical registration requires free sale certificate and GMP certificate from country of origin
- Post-market surveillance and adverse event reporting systems must be established after registration
Panama specific Requirements
- Panama implements strict Spanish language labeling and documentation system
- All technical documentation must be in Spanish with certified translation
- Medical devices follow I-III risk classification system
- Pharmaceutical registration requires complete technical documentation and stability data
- Must conduct registration applications through authorized representatives in Panama
- Emphasis on quality system certification and good manufacturing practice compliance
Medical Devices Registration
Regulatory Requirements
- Medical Device Health Registration (Registro Sanitario)
- Classification Management by Risk Level (Class I, II, III)
- Complete Spanish Technical Documentation
- Quality Management System Certificate (ISO 13485)
- Free Sale Certificate and Certificate of Origin
- Product Performance Test Reports
- Biocompatibility Test Reports (if applicable)
- Electrical Safety Certification (if applicable)
- Clinical Evaluation Report (Class 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 - $5,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health Panama
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 Panama.
Dirección de Farmacia
Directorate of Pharmacy and Drugs
Responsible for specific registration approval, technical evaluation, and post-market surveillance of pharmaceuticals and medical devices
Aduanas
National Customs Authority of Panama
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Panama medical device regulations (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 Panama responsible for registration and regulatory affairs
Ministry of Health Application
Submit medical device health registration application to Panama Ministry of Health
Technical Review
Pass Ministry technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Health Registration Certificate
- Ingredient Safety Assessment Report (Spanish)
- Spanish Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Stability Study Report
- Microbiological Test Reports
- Prohibited and Restricted Ingredients Compliance Proof
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Local Representative Appointment
- Health Registration Application
- Labeling Review Preparation
Registration Timeline
4-8 months
Official Fees
$500 - $3,000
Service Fees
$6,000 - $16,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health Panama
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 Panama.
Dirección de Farmacia
Directorate of Pharmacy and Drugs
Responsible for specific registration approval, technical evaluation, and post-market surveillance of pharmaceuticals and medical devices
Aduanas
National Customs Authority of Panama
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Panama 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 Panama 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 Panama cosmetic labeling regulations
Pharmaceuticals Registration
Regulatory Requirements
- Pharmaceutical Health Registration Certificate
- Complete Quality, Safety and Efficacy Data Package
- Stability Study Data (ICH Guidelines)
- Good Manufacturing Practice Certification
- Free Sale Certificate
- Analytical Methods and Validation Data
- Bioequivalence Studies (for generic drugs)
- Pharmacopoeia Compliance Proof
Main Process
- Product Classification Confirmation
- Registration Dossier Preparation
- Local Representative Appointment
- Health Registration Application
- Technical Review Coordination
Registration Timeline
8-18 months
Official Fees
$1,500 - $8,000
Service Fees
$18,000 - $45,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health Panama
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 Panama.
Dirección de Farmacia
Directorate of Pharmacy and Drugs
Responsible for specific registration approval, technical evaluation, and post-market surveillance of pharmaceuticals and medical devices
Aduanas
National Customs Authority of Panama
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 registration classification
Registration Dossier Preparation
Prepare complete Spanish technical documentation and registration materials
Local Representative Appointment
Appoint authorized representative in Panama 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