This article has been updated on May 29, 2025 and provides a general overview of the current medical device regulations in Paraguay.
Medical device regulations in Paraguay are set forth by the Direccion de Viglancia Sanitaria (DINVISA) del Ministerio de Salud Publica y Bienestar Social (MSPBS).
Medical device oversight in Paraguay has evolved quickly since 2019. The DINAVISA operates a fully-digital submission portal, applies a four-tier risk classification, and issues 10-year marketing certificates that align with the latest MERCOSUR framework.
Below you will find a concise guide to the current requirements, recent changes and practical tips for bringing your device to the Paraguayan market.
- Key Updates (2020 – 2025)
- DINAVISApy e-Portal (2023) – all applications, renewals and post-approval changes must now be lodged online.
- Resolution 202/2023 – introduces risk-based GMP/GDP inspections of manufacturers, importers and distributors.
- Resolution 226/2024 – establishes Classes I–IV (mirroring MERCOSUR GMC 25/21), sets 10-year certificate validity and creates self-declaration renewals for Class I.
- Resolution 352/2024 – allows remote inspections via live video and secure document sharing.
- Resolution 44/2024 – streamlines IVD registration if already cleared by a reference authority (EU, FDA, ANVISA, etc.).
- 2024–25 public consultation – Paraguay is finalising full transposition of MERCOSUR GMC 25/21; adoption expected Q4 2025.
- Device Classification
|
Class |
Risk Level |
Examples |
|---|---|---|
|
I |
Low |
Bandages, surgical gloves |
|
II |
Low–medium |
Syringes, dental materials |
|
III |
Medium–high |
Infusion pumps, orthopaedic implants |
|
IV |
High |
Pacemakers, heart valves |
IVDs use a separate A–D risk scale; Class A IVDs benefit from the simplified route in Resolution 44/2024.
- Registration Pathway
- Appoint a local Registration Holder. A Paraguayan entity authorised by DINAVISA is mandatory.
- Prepare the technical dossier in Spanish (per DINAVISA checklist SG 669/16):
- Administrative forms, legalised Power of Attorney and Quality Agreement.
- ISO 13485 or MDSAP certificate and evidence of GMP compliance.
- Device description, risk analysis, labelling/IFU and summary clinical evidence.
- Submit via DINAVISApy. Pay fees electronically and monitor queries in the portal.
- Regulatory review timeline:
- Class I – ≈ 30 days (self-declaration)
- Class II – 60–90 days
- Class III – 90–120 days
- Class IV – 120–180 days
- Certificate issuance. DINAVISA grants a Certificado de Registro Sanitario (10-year validity) and lists the device in the public database.
- Certificate Validity, Changes & Renewals
- Certificates and obligatory Notificación Sanitaria both last 10 years and are renewable for equal periods.
- Class I renewals: electronic sworn declaration.
Classes II–IV: updated dossier plus proof of continued GMP. - Post-authorisation changes (labelling, design, manufacturing site, etc.) must be approved through DINAVISApy under the categories defined in Resolution 226/2024.
- Fees (2025)
DINAVISA updates fees annually under SG 784/16. Current base fees:
- Class I – PYG 1 300 000
- Class II – PYG 2 000 000
- Class III – PYG 3 300 000
- Class IV – PYG 5 000 000
A 30 % surcharge applies to combination products; micro-enterprises receive a 50 % discount (Res. 265/2023).
- Quality Management & Inspections
DINAVISA recognises ISO 13485 and MDSAP but verifies local compliance through:
- On-site or remote audits per Resolution 352/2024 (every 3–5 years or upon major changes).
- Corrective Action Plans: Class II findings – 90 days to close; Class III findings – potential suspension of the marketing authorisation.
- Labelling & Unique Device Identification
- All labels must be in Spanish and display country of origin, importer address, expiry date (where applicable) and MERCOSUR hazard symbols.
- UDI is voluntary; DINAVISA encourages GS1 codes for Class III–IV implants.
- Post-Market Surveillance
- Adverse incidents – report within 15 calendar days.
- Trend reports – submit within 90 days.
- Field Safety Corrective Actions – require prior DINAVISA approval and public notice within 48 hours.
- Implant tracking card – mandatory for implantables (Annex V, Res. 226/2024).
- Practical Tips for 2025
- Upload searchable PDF documents under 10 MB each to avoid portal rejections.
- Use the simplified pathway for IVDs and low-risk devices already cleared in the EU, USA or Brazil.
- Maintain an audit-ready local warehouse – DINAVISA is increasing random GDP checks.
- Monitor DINAVISA consultations: adoption of MERCOSUR GMC 25/21 may re-classify devices in late 2025.
