Paraguay Medical Device Registration 2026: DINAVISA Fees (Aranceles) and Life-Cycle Cost Planning

1. Key takeaways

1. Article 35: the fees (aranceles) are set by the Dirección General de Administración y Finanzas of DINAVISA according to the categorization by class (según categorización de clase). The fee-setting competence therefore sits with an administrative-financial body inside the authority, not with the drafting of the resolution itself.
2. The fees are not stated in the body of the resolution — Resolución DINAVISA N° 226/2024 says throughout only abonar el arancel correspondiente (pay the corresponding fee) and lists no amounts. Any figure quoted from the resolution text itself is by definition unsupported.
3. The points at which fees fall due include: the initial registration application; a re-application after the class declaration is rejected (Articles 4 and 26); every single post-market change (Article 13); and the renewal application.
4. Any specific fee amount that appears in external quotations or commitments and cannot be traced to the current official DINAVISA fee schedule should be labeled a practical estimate and must not serve as a contractual basis.

2. Legal basis

Ley N° 6788/2021 gives DINAVISA its autonomous mandate, including the power to issue regulations and collect fees; Article 35 of the resolution then delegates the concrete amounts to the administrative-financial directorate by device class. The two layers must be read together to understand why no fixed schedule appears in the resolution.

The class-based structure of the fee regime also means that a portfolio decision can move money as well as paperwork. Because fees follow the categorization by class, the fee for the same filing event differs across classes, and a product family split across classes will produce different cost lines for identical administrative steps. Companies planning multi-class portfolios should therefore budget per class and per filing event, rather than per project, and should record which filing events trigger fees — initial applications, re-applications after rejection under Articles 4 and 26, each post-market change under Article 13, and renewals — so that the finance team can model scenarios before commitments are made to distributors or customers.

3. Expert insights

Insight one: the delegation of fee-setting power is a direct expression of the authority’s autonomous status. Article 35 hands pricing to the Dirección General de Administración y Finanzas instead of freezing amounts in the resolution. The benefit is that fees can track costs and inflation; the price of that flexibility is that companies cannot obtain amounts by reading the resolution and must always work from the current official fee schedule. Budget owners should treat the schedule as a living input, refreshed at every project gate, rather than a one-time lookup.

Insight two: a fee for every change materially changes the life-cycle cost model. Article 13 requires payment of the corresponding fee for each modification (abonar el arancel correspondiente por cada modificación). With a certificate valid for 10 years, label redesigns, address changes, and model extensions during the holding period all generate fees. A ten-year total cost of ownership calculation that omits this line will understate the real cost of holding the certificate, particularly for product families with frequent packaging or configuration updates.

Insight three: a re-application after rejection also requires payment again. Article 4 (re-filing after the class declaration is rejected) and Article 26 (re-application after an application is rejected) both state that the corresponding fee must be paid. Poorly managed deadlines therefore have a direct financial consequence: every rejected filing converts into a second fee event plus additional elapsed time, which is why deadline discipline belongs in the finance plan as well as the regulatory plan.

Insight four: the fee regime rewards dossier quality in a way that companies can quantify. Because a rejected application or a rejected class declaration converts into a second fee event under Articles 4 and 26, the expected cost of a filing is not just its base fee but base fee plus the probability-weighted cost of rejection and the elapsed time that comes with it. Improving pre-submission review — checking the class declaration, the documentary set, and the translation quality — is therefore a direct cost measure, not merely a regulatory nicety. Finance and regulatory teams can model this together: every percentage point of reduction in the rejection rate translates into avoided fees and avoided delay in the plan.

4. Practical recommendations

1. In the budget model, list fees as a separate line settled according to the current official DINAVISA fee schedule, with an allowance for annual adjustments.
2. Include the fee per change in life-cycle cost calculations, estimated from the expected change frequency over the 10-year validity.
3. Include the cost of a re-filing after rejection in the project risk reserve, so a rejection does not force an unplanned budget request.
4. For any fee figure supplied by a third party, require the source in the official fee schedule; without a source, the figure must not be written into quotations or commitments to clients.
5. Reconcile actual fees paid against the budget at each project milestone, and feed the observed amounts and adjustment trends back into the model, so the fee line improves in accuracy over the life of the certificate.
6. Keep the archived fee schedule versions together with the payment receipts, so the amount charged for any historical filing event can be evidenced years later during audits or portfolio reviews.

5. Verification checklist

• □ Quotations contain no fixed fee amounts (practical estimate)
• □ Current official DINAVISA fee schedule obtained and archived
• □ Life-cycle costs include the fee for each change
• □ Risk reserve includes the re-filing fee after rejection
• □ All third-party fee figures verified against a source

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers, and authorized representatives, covering fee planning, life-cycle cost modeling, and budget governance. Contact info@grzanglobal.com for tailored guidance on this topic.