Paraguay Product Registration Certification
Important Notes
- Dual Regulation by INAN & MoH: Pharmaceuticals and medical devices are regulated by the MoH; foods and cosmetics by the National Institute of Food and Nutrition, both requiring sanitary registration.
- Dietary Supplements as Foods for Special Purposes: Clearly classified, registration requires full formula, safety evidence, and labeling. Claim management is strict, prohibiting any therapeutic or disease prevention implications.
- Mandatory Local Agent/Importer System: A foreign manufacturer must appoint a locally registered Paraguayan company as the legal agent/importer to submit the application and act as the responsible party.
- Spanish/Guarani Bilingual Labeling Requirement: Primary commercial labeling must include both Spanish and Guarani, a unique mandatory language requirement in Paraguay.
- Simplified Price Registration & Free Pricing: Most products have free pricing with only a sales price registration at the MoH. Government tenders set separate price limits.
- Regulatory Alignment as a MERCOSUR Member: As a member, some of Paraguay’s technical regulations align with MERCOSUR resolutions.
Paraguay Specific Requirements
- Small but Open South American Inland Market: The market size is modest but with open trade policies and high economic freedom, serving as a reference point for testing product acceptance in the interior region.
- Parallel Public Procurement & Private Pharmacy Channels: Public procurement focuses on essential drugs, while ubiquitous private pharmacies are the main retail channel for consumer health products.
- Direct & Concentrated Distribution Channels: The small size leads to simpler distribution layers centered in Asunción, enabling quick coverage of major cities, though rural penetration remains a challenge.
- High Reference Value from Neighboring Markets: Market dynamics are significantly influenced by Brazil and Argentina, making trends in these large neighbors instructive for Paraguay.
- Pragmatic & Flexible Regulatory Enforcement: There can be practical flexibility within the formal framework, making collaboration with local experts important.
Medical Devices Registration
Regulatory Requirements
- DINAVISA Health Registration (Registro Sanitario)
- Risk-based classification system (Class I-III)
- Technical documentation and test reports
- Spanish labeling and instructions for use
- Quality Management System compliance
- MERCOSUR Technical Regulations compliance
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Electrical safety certification (where applicable)
Main Process
- Product classification determination
- Technical documentation preparation
- DINAVISA review submission
- Quality management system audit
- Registration certificate acquisition
Registration Timeline
6-12 months
Official Fees
PYG 2,500,000 - 15,000,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
DINAVISA
National Directorate of Health Surveillance (Dirección Nacional de Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Paraguayan Ministry of Public Health and Social Welfare, operating within MERCOSUR regulatory framework.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-III) according to DINAVISA and MERCOSUR guidelines
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports and performance data
Local Representative Appointment
Designate Paraguayan Authorized Representative as required by DINAVISA regulations
DINAVISA Application Submission
Submit Medical Device Health Registration application with all supporting documentation
Post-Market Surveillance
Establish vigilance system and adverse event reporting requirements
Cosmetic Products Registration
Regulatory Requirements
- DINAVISA Health Registration (Registro Sanitario)
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- MERCOSUR Technical Regulations compliance
- Product safety data and toxicological information
- Microbiological quality specifications
- Stability study documentation
- Manufacturing process description
- Quality control procedures
Main Process
- Ingredient formulation assessment
- Label review preparation
- DINAVISA registration submission
- GMP system establishment
- Technical documentation maintenance
Registration Timeline
3-6 months
Official Fees
PYG 600,000 - 3,000,000
Service Fees
$4,000 - $11,000
Regulatory System Overview
DINAVISA
National Directorate of Health Surveillance (Dirección Nacional de Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Paraguayan Ministry of Public Health and Social Welfare, operating within MERCOSUR regulatory framework.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with DINAVISA and MERCOSUR requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with DINAVISA cosmetic regulations
Health Registration Submission
Submit Cosmetic Health Registration application to DINAVISA
GMP System Implementation
Establish Good Manufacturing Practices quality system
Technical Documentation Maintenance
Maintain complete product technical file and compliance records
Health Supplements Registration
Regulatory Requirements
- DINAVISA Health Registration (Registro Sanitario)
- Ingredient safety and efficacy evidence
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Scientific basis for health claims
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Product formulation details
Main Process
- Product classification confirmation
- Technical documentation preparation
- DINAVISA registration submission
- Scientific review assessment
- Registration certificate acquisition
Registration Timeline
4-8 months
Official Fees
PYG 1,200,000 - 5,000,000
Service Fees
$6,000 - $15,000
Regulatory System Overview
DINAVISA
National Directorate of Health Surveillance (Dirección Nacional de Vigilancia Sanitaria)
Responsible for medical devices, cosmetics, health supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Paraguayan Ministry of Public Health and Social Welfare, operating within MERCOSUR regulatory framework.
Health Supplements Registration Process
Regulatory Classification
Confirm product classification as health supplement under Paraguayan regulatory framework
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and supporting documentation
Local Representative Appointment
Designate Paraguayan Authorized Representative for regulatory submissions
DINAVISA Registration Submission
Submit Health Supplement Registration application to DINAVISA
Post-Market Compliance
Establish quality monitoring system and compliance framework