Paraguay Medical Device Registration
Important Notes
- Dual Regulation by MoH & DINAVISA: Medical devices are regulated by the Ministry of Public Health, requiring sanitary registration before import and sale.
- Risk-Based Device Classification: Medical devices are classified into Class I-III based on risk level, with differentiated registration pathways and technical documentation requirements.
- 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 medical devices 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 medical device 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 medical device acceptance in the interior region.
- Parallel Public Procurement & Private Channels: Public procurement focuses on essential medical devices, while private hospitals and clinics are the main channels for premium and specialized medical equipment.
- 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: Medical device 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 for medical device registration.
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 device registration approvals, quality supervision, and market surveillance. The primary regulatory authority under the Paraguayan Ministry of Public Health and Social Welfare, operating within the 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