Sanitary licence validity: 2, 4 or 6 years and Article 17 requirements

1. Key takeaways

The validity of the Honduran Licencia Sanitaria (sanitary licence) is chosen by the applicant: Article 12 of Acuerdo No. 0631-ARSA-2023 provides for a validity of 2, 4 or 6 years, counted from the date of issue, determined according to the applicant’s choice and the service recovery fee paid. The processing deadline for new licences and renewals is 60 working days (Acuerdo No. 003-2021, La Gaceta No. 35,552, 2021-03-23, item CUARTO, table 2), and the document list is set out in the 11 items of Article 17. The GRZAN regulatory team flags one mismatch that must be noted: the Vigencia column of table 2 of Acuerdo 003-2021 still states 2 years. That fee schedule was published in 2021, before Acuerdo 0631-ARSA-2023 (published 2024-09-21), and no official update of the fees for the 4-year and 6-year tiers alongside the new regulation has been observed. How the 4-year and 6-year tiers are charged currently has no officially verifiable basis and must follow the payment notice issued by ARSA at the time.

2. Legal basis

The framework combines the substantive licence rules of Acuerdo No. 0631-ARSA-2023 with the fee tables of Acuerdo No. 003-2021. The table below consolidates the provisions on validity, obligations, documents, prohibitions and the fee fractions, which are expressed as fractions of the Salario Mínimo Promedio (average minimum wage).

3. Expert insights

Insight 1: validity is bought, not granted. Article 12 ties the validity period directly to the service recovery fee paid, and the applicant may choose among three tiers. This reshapes the budgeting model: the cost of the licence is not a fixed figure but varies with the combination of term and activities. A company taking a 6-year term while operating import, distribution and commercialisation commits a materially higher initial outlay than a company taking a 2-year term for a single activity.

Insight 2: multiple activities are charged by accumulation, not as a package price. Point 1 of the explanatory notes to item CUARTO of Acuerdo 003-2021 states that for premises operating more than one activity, the base price equals the sum of the service recovery fees of all activities applied for. Applying for one licence covering every activity therefore does not save money. The scope of activities should map one-to-one to the real business; otherwise an activity-expansion change must later be made under Article 20, with additional fees.

Insight 3: online filing is cheaper than on-site filing, and the gap is stable. Across the two fee sets in table 1, the online tier is generally lower than the on-site tier. Taking Importar as an example, the on-site fee is 1/35 and the online fee 1/45 of the average minimum wage. This is not a token difference: under accumulated pricing, a multi-activity company choosing the online channel directly compresses its initial government fees.

Insight 4: the application heading must be copied verbatim. The heading given in Article 17, item 1 is SE SOLICITA NUEVA LICENCIA SANITARIA PARA ESTABLECIMIENTO DE DISPOSITIVOS MÉDICOS Y OTROS DISPOSITIVOS DE INTERÉS SANITARIO, and the application form must contain 11 data points, a to k, of which point (i) is the request for a 2-, 4- or 6-year validity. A defective heading or missing data point is a formal defect and will be rejected at the window-acceptance stage.

Insight 5: additional warehouses are billed separately. Article 17, item 11 sets out 4 documents specifically for an additional warehouse whose address differs from the main premises, and expressly requires proof of payment for the additional storage activity. Separating the storage address from the operating address is a common structure, but it generates an additional payment slip and an additional set of on-site documents (exterior and interior photographs, a sketch of the internal layout and a location sketch).

Insight 6: the time gap between the new regulation and the fee schedule must be managed. Acuerdo 0631-ARSA-2023 extended validity to three tiers, while the fee schedule of Acuerdo 003-2021 (2021) only prices the 2-year tier. GRZAN does not infer the amounts for the 4-year and 6-year tiers from this gap; all amounts follow the payment notice issued by ARSA at the time, with a practical estimate and float reserved in the project budget.

4. Practical recommendations

• Fix the operating term before fixing the budget: choose 2, 4 or 6 years according to the market plan and confirm the current fee for that tier with ARSA; do not apply the 2-year base of table 2 of Acuerdo 003-2021 to longer terms.
• Select activities according to the actual business: apply only for activities that will genuinely be carried out, to avoid inflated accumulated base prices and later change applications to remove activities.
• Prefer the online channel: for the same activity the online fee is lower than the on-site fee, and the 60-working-day deadline of table 2 applies equally to both channels.
• Copy the Article 17, item 1 heading exactly and verify the 11 data points a–k one by one, in particular not omitting the validity choice at point (i).
• Where an independent warehouse exists, file the 4 documents of Article 17, item 11 together with the additional payment voucher in the same batch, to avoid a second queue.
• Use the table 4 expedited tiers only under launch pressure: 40 working days at 3/2×, 20 at 2× and 10 at 3×, but first confirm that ARSA has current intake capacity (that table is expressly conditional on institutional capacity to accept).

5. Verification checklist

• □ Operating term (2/4/6 years) has been decided and entered at point (i) of the application
• □ List of activities applied for has been aligned item by item with the actual business
• □ Precio base calculated under table 1 has been checked against the current ARSA payment notice
• □ Application heading and the 11 data points a–k have been verified verbatim
• □ Articles of association, location sketch, internal layout and exterior and interior photographs are complete
• □ Technical director professional card (where applicable) and the current format of the sworn statement have been confirmed
• □ The 4 supplementary documents and additional payment voucher for the independent warehouse are ready

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

Regulatory information verified as of October 29, 2026.