Honduras Product Registration & Certification
Important Notes
- All registration documents submitted to the Honduran Ministry of Health must be in Spanish or certified Spanish translations.
- Registration applications must be submitted through a locally appointed Authorized Representative (Representante Legal).
- Products must comply with the relevant Central American Technical Regulations (RTCA).
- The Sanitary Registration Certificate is typically valid for 5 years and requires renewal before expiration.
- Product labels and instructions must be in Spanish and comply with local labeling regulations.
Honduras specific Requirements
- The regulatory framework is based on the Central American Technical Regulations (RTCA).
- All technical documentation and instructions for use must be in Spanish (mandatory).
- A local Authorized Representative must be appointed for registration applications.
- Emphasis is placed on the manufacturer's Quality Management System certification status.
- A validity management system is in place for Sanitary Registration Certificates, requiring periodic renewal.
Medical Devices Registration
Regulatory Requirements
- Medical Device Sanitary Registration (Registro Sanitario)
- Classification according to Central American Technical Regulations (RTCA 11.04.42:10)
- Complete Technical File in Spanish
- Quality Management System Documentation (ISO 13485)
- Certificate of Free Sale from Country of Origin
- Product Performance and Safety Verification Reports
- Conformity Assessment Documents
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Performance Verification Completion
- Ministry of Health Registration Application
- Technical Review and Approval
Registration Timeline
4-6 Months
Official Fees
$450 - $3,200
Service Fees
$5,500 - $15,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health (Ministerio de Salud)
Comprehensively responsible for the sanitary registration approval of medical devices, cosmetics, and pharmaceuticals, post-market safety monitoring, and market supervision. It is the core regulatory body for health products in Honduras.
Medical Devices Registration Process
Determine Product Classification
Determine medical device risk class (I, II, III, IV) according to RTCA 11.04.42:10 regulations.
Prepare Technical Documentation
Compile complete technical file in Spanish, including QMS documentation.
Performance & Safety Verification
Complete necessary product performance testing, biocompatibility, and safety verification.
Submit Registration Application
Submit medical device registration application to the Ministry of Health via the local authorized representative.
Technical Review & Approval
Cooperate with the Ministry of Health during technical review and obtain the Sanitary Registration Certificate.
Cosmetics Registration
Regulatory Requirements
- Cosmetic Sanitary Registration (Registro Sanitario)
- Cosmetic Product Safety Report (CPSR)
- Complete Product Information File (PIF) in Spanish
- Good Manufacturing Practices (GMP) Certificate
- Product Stability Test Report
- Label Compliance Review (Spanish)
Main Process
- Ingredient Formulation Assessment
- Safety Dossier Preparation
- Sanitary Registration Application
- Label Compliance Review
- Market Surveillance Filing
Registration Timeline
3-4 Months
Official Fees
$350 - $1,600
Service Fees
$4,000 - $10,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health (Ministerio de Salud)
Comprehensively responsible for the sanitary registration approval of medical devices, cosmetics, and pharmaceuticals, post-market safety monitoring, and market supervision. It is the core regulatory body for health products in Honduras.
Cosmetics Registration Process
Assess Ingredient Formulation
Review cosmetic ingredients for compliance with Honduran regulations and safety.
Prepare Safety Dossier
Compile the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR).
Submit Registration Application
Submit cosmetic sanitary registration application to the Ministry of Health via the local authorized representative.
Label Compliance Review
Ensure Spanish labeling meets local regulatory requirements, such as RTCA 71.01.60:10.
Market Surveillance Filing
Complete post-market regulatory filing procedures.
Pharmaceuticals Registration
Regulatory Requirements
- Pharmaceutical Sanitary Registration (Registro Sanitario)
- Complete Common Technical Document (CTD) or eCTD
- Proof of Quality, Safety, and Efficacy
- Stability Study Protocol and Report
- Good Manufacturing Practices (GMP) Certification
- Marketing Authorization Proof from Country of Origin
Main Process
- Confirm Product Category & Registration Pathway
- Prepare Registration Dossier
- Submit Sanitary Registration Application
- Cooperate with Technical Review
- Obtain Registration and Fulfill Post-Market Obligations
Registration Timeline
6-9 Months
Official Fees
$900 - $4,500
Service Fees
$11,000 - $22,000
Regulatory System Overview
Ministerio de Salud
Ministry of Health (Ministerio de Salud)
Comprehensively responsible for the sanitary registration approval of medical devices, cosmetics, and pharmaceuticals, post-market safety monitoring, and market supervision. It is the core regulatory body for health products in Honduras.
Pharmaceuticals Registration Process
Confirm Product Category & Pathway
Define the regulatory category (e.g., prescription, OTC, biologics) and corresponding registration requirements.
Prepare Registration Dossier
Compile a complete registration dossier (e.g., CTD) in Spanish as required.
Submit Registration Application
Submit pharmaceutical registration application to the Ministry of Health via the local authorized representative.
Cooperate with Technical Review
Respond to queries or requests for additional information from the Ministry of Health during the technical review.
Post-Market Surveillance
Establish a pharmacovigilance system and fulfill post-market obligations such as periodic reporting.