Government fees and the single payment rule

1. Key takeaways

The technical regulation itself lists no amounts. Its payment clauses all use the same formula — Cancelación del pago o arancel definido por el Ministerio según decreto, payment of the fee or tariff defined by the Ministry by decree — appearing in Article 11.10 (registration), Article 17.2.6 (mutual recognition relief), Article 16.11 (renewal) and throughout the change provisions of Article 18. The statutory source of the government fees is Decreto Ejecutivo N° 32780 (2005-10-25, La Gaceta N° 232, 2005-12-01), the decree establishing the tariffs to support the processing, registration and inspection, vigilance and control functions for EMB, which the regulation lists as a reference document in Article 3.4. This volume has not obtained the current text of that tariff schedule and therefore quotes no specific figures; the dollar amounts circulating in industry service pages are a practical estimate only and must be confirmed against the Ministry of Health’s current published rates.

2. Legal basis

The provisions below locate the payment obligation in each procedural stage, fix the one-application-one-payment rule, and identify the decree that constitutes the legal source of the tariffs.

3. Expert insights

Insight 1: one application, one payment is the only deterministic fee rule in the regulation, and it sits inside the grouping clause. The final sentence of Article 10.7 reads: En todos los casos un único trámite implicará un único pago. The meaning is that no matter how many family members, system components or test kit constituents are combined, only one fee is charged. This is a rule strongly favourable to applicants and one of the core economic benefits of the grouping cases (covered in a dedicated article of this series). Conversely, Article 10.8 — under which products with different constituents must be registered separately — implies separate payments. The fee consequence of the grouping decision is therefore real money, not a formality.

Insight 2: the payment obligation covers nearly every procedural stage of the regulation. Registration (11.10), mutual recognition relief (17.2.6) and renewal (16.11) all require payment; and of the nineteen categories of post-registration change in Article 18, all except Article 18.4 (change of legal representative) and Article 18.19 carry fee items (18.1.3, 18.2.4, 18.3.7, 18.5.3, 18.6.2, 18.7.2, 18.8.3, 18.9.8, 18.10.6, 18.11.6, 18.12.5, 18.13.4, 18.14.4, 18.15.4, 18.16.9, 18.17.3, 18.18.2, 18.19.2). The budgeting implication is direct: costs should be estimated by number of procedures, not by number of products, because each procedural event triggers its own fee even when the underlying portfolio is small.

Insight 3: the statutory source of the fees is a 2005 decree — more than twenty years old — which is itself a signal to re-verify. The tariff decree cited in Article 3.4 was issued in 2005. Whether it has been amended since, and what the current tariff schedule reads, could not be confirmed from official text for this volume. The figures circulating on industry service pages — Class 2 at 25 US dollars, Class 3 and 4 at 50 US dollars — have not been located in any official text and are listed here as not adopted. Before quoting costs to stakeholders, companies should confirm the current rates with the Ministry of Health or through the Regístrelo portal.

Insight 4: writing the amounts as pending verification into external documents is compliance, not evasion. Because the regulation points the amounts at a 2005 decree and the current text could not be verified, any specific figure risks misleading timelines and budgets. The correct practice is to state in quotations and project plans that the government fees follow DE 32780 and the rates currently published by the Ministry of Health, as applicable at the time of filing, and to reserve a re-verification checkpoint before submission. This converts an uncertainty into a managed item rather than an assumed number.

4. Practical recommendations

• Budget by number of procedures: one fee for registration, one for renewal, and one for each category of post-registration change; grouped filings count once under Article 10.7.
• Before filing, verify current rates with the Ministry of Health or the Regístrelo portal; do not carry over industry-circulated dollar figures.
• Use grouping as a cost-optimisation lever: group every eligible case to exploit the one-application-one-payment rule.
• Flag the fee amounts as a pending verification item in the cost model, annotated as governed by DE 32780 and current Ministry publication, with a re-verification checkpoint.
• Retain each payment receipt and link it to the application number for retrieval at renewal and during audits.

5. Verification checklist

• □ Payment obligation confirmed under Article 11.10
• □ Grouped filings apply the single payment rule under Article 10.7
• □ Statutory source status of DE 32780 checked (Article 3.4)
• □ Budget estimated by procedures, not by product count
• □ Fee amounts flagged as pending verification; industry figures not adopted
• □ Payment receipts archived and linked to application numbers

Related reading: [Seven grouping cases: one application, one registration number, one payment](/costa-rica-medical-device-registration/seven-grouping-cases-single-registration/) | [Five-year registration validity and the eleven renewal items](/costa-rica-medical-device-registration/five-year-validity-and-renewal-eleven-items/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com