The regulatory landscape in Paraguay requires a clear understanding of the investment involved. At OMC Medical, we believe in transparency. The following cost breakdown provides estimates for registering all classes of medical devices with the Dirección Nacional de Vigilancia Sanitaria (DINAVISA).
Disclaimer: The figures below are estimates for planning purposes. Final costs are subject to variation based on device complexity, risk profile, specific DINAVISA requirements. This is not a formal quotation.
Paraguay Medical Device Registration Costs
Understanding the fees and requirements is essential for a smooth market entry into Paraguay’s healthcare sector.
Summary of Estimated Costs by Device Class (USD)
| Device Class | Risk Level | Estimated Gov’t Fee (USD) | Estimated Service Fee (USD) | Key Examples |
| Class I | Low | $500 – $800 | $1,500 – $3,000 | Non-sterile dressings, examination gloves, reusable surgical instruments. |
| Class IIa | Low-Medium | $700 – $1,000 | $2,500 – $5,000 | Hypodermic needles, suction equipment, urinary catheters. |
| Class IIb | Medium-High | $1,000 – $1,500 | $3,000 – $7,000+ | Ventilators, infusion pumps, surgical lasers, blood bags. |
| Class III | High | $1,500 – $2,200 | $5,000 – $10,000+ | Heart valves, pacemakers, drug-eluting stents, implantable prosthetics. |
Detailed Cost Breakdown
1. Government Fees (Payable to DINAVISA)
DINAVISA fees are based on the national tax unit (Unidad de Valor Tributario – UVT) and are scaled according to the risk class of the device. Higher-risk devices incur higher fees due to the more complex review process.
- Class I: Lower complexity review. ~$500 – $800
- Class IIa: Standard complexity review. ~$700 – $1,000
- Class IIb: Elevated complexity review. ~$1,000 – $1,500
- Class III: Highest complexity, extensive review. ~$1,500 – $2,200
These fees are non-refundable, even if the application is unsuccessful.
2. OMC Medical Service Fees
Our service fees are tailored to the workload and expertise required for each device class. Our end-to-end service includes:
- Regulatory Strategy & Classification Confirmation
- Full Dossier Preparation, Compilation, & Submission
- Acting as your mandatory Local Legal Representative (Qualified Person – QPP)
- Direct Liaison with DINAVISA Authorities
- Translation of Technical Documentation and Labeling
- Project Management & Ongoing Guidance
3. Ongoing and Recurring Fees
Maintaining your device on the Paraguayan market involves predictable annual costs:
- Annual Sanitary Surveillance Fee (DINAVISA): An annual tax for each registered device. ~$300 – $1,000 USD/year (scales with device class).
- Local Legal Representative (QPP) Retainer (OMC Medical): Our annual fee to maintain your compliance and act as DINAVISA’s point of contact. ~$1,000 – $2,500+ USD/year
- License Renewal: Registrations are valid for 5 years. Renewal involves government fees (similar to initial application) and a reduced service fee. ~$1,500 – $4,000+ USD every 5 years.
Why Costs Vary
The final cost for your specific device depends on several factors:
- Device Complexity: A novel Class III device will be at the top of the range, while a well-established Class I device will be at the bottom.
- Technical File Readiness: Costs are lower if your technical documentation (e.g., technical file, labels, IFU, clinical data) is complete and well-prepared for the MERCOSUR framework.
- Number of Devices: Portfolio applications for multiple devices from the same manufacturer can often be bundled for a more favourable total cost.
Your Next Steps with OMC Medical
Receiving a precise quote is simple.
- Provide Device Details: Share the device name, intended use, and classification (if known).
- Share Technical Documentation: The more complete your existing technical file is, the more accurate our quote will be.
- Receive a Tailored Proposal: We will provide a transparent, detailed proposal (propuesta comercial) outlining all expected government and service fees specific to your product.
Let OMC Medical demystify the process and provide a clear path to market.
Sales@omcmedical.com today for your personalized, no-obligation quotation.
