El Salvador Product Registration & Certification
Important Notes
- Mandatory Spanish: All documents submitted to Ministry of Health must be in Spanish or certified translations
- Legal Representative System: Registration applications must be submitted through local authorized representative (Representante Legal)
- RTCA Regulation Compliance: Products must comply with Central American Technical Regulations (RTCA) requirements
- Registration Validity: Health registration certificates valid 5 years requiring renewal before expiration
- Labeling Requirements: Product labels and instructions must be in Spanish complying with local regulations
- Document Authentication: Key documents require origin country notarization and Salvadoran consular authentication
- Quality Management: QMS receives thorough review for medium-high risk product registrations
El Salvador specific Requirements
- Central American Regulatory Framework: Regulatory system based on RTCA technical regulations framework
- Mandatory Spanish Requirement: All technical documents and instructions must be in Spanish
- Mandatory Authorized Representative System: Must appoint local authorized representative for registration
- Quality Management Emphasis: Emphasizes manufacturer's quality management system certification status
- Registration Certificate Validity Management: Implements health registration certificate validity system requiring periodic renewal
- Regional Coordination: As Central American integration member participates in regional regulatory coordination
- Traditional Medicine Status: Maintains special regulatory provisions for traditional medicines and herbal products
Medical Devices Registration
Regulatory Requirements
- Medical Device Sanitary Registration (Registro Sanitario)
- Classification according to Central American Technical Regulations (RTCA)
- Complete Technical File in Spanish
- Quality Management System Documentation (e.g., 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
$400 - $3,000
Service Fees
$5,000 - $14,000
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 El Salvador.
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
$300 - $1,500
Service Fees
$3,500 - $9,000
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 El Salvador.
Cosmetics Registration Process
Assess Ingredient Formulation
Review cosmetic ingredients for compliance with Salvadoran 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
6-8 Months
Official Fees
$800 - $4,000
Service Fees
$10,000 - $20,000
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 El Salvador.
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.