Honduras Medical Device Legal Framework

1. Key takeaways

The legal sources for devices in Honduras can be arranged in 4 layers: the Constitution (Articles 145 and 146, right to health protection and the regulatory duty of the State); laws and decrees (Decreto No. 7-2021, the ARSA law, and the Código de Salud); regulations (Acuerdo No. 0631-ARSA-2023, the sanitary control regulation for devices, and Acuerdo No. 0185-ARSA-2025, the technovigilance regulation); and administrative resolutions (Acuerdo No. 003-2021 and Acuerdo No. 012-2020, which set processing deadlines and service fees). The main regulation 0631-ARSA-2023 was signed in Comayagüela on 2023-12-28 and published in La Gaceta No. 36,646 of 2024-09-21; its SECOND provision sets entry into force 20 days after publication. Article 89 sets the supplementary order of application: treaties and conventions, the Health Code, the Civil Procedure Code, the General Law of Public Administration, the Administrative Procedures Law, general principles of law, and the technical provisions issued by ARSA on its own initiative.

• Treating 0631-ARSA-2023 as the only basis misses fees and deadlines: those sit in Acuerdos 012-2020 and 003-2021.
• The device regulation and the technovigilance regulation entered into force on different dates, so compliance calendars must mark two switching points.
• The main fee table of Acuerdo 012-2020 exists only as an image, so amounts are pending verification and only the pricing basis can be cited.

2. Legal basis

The four layers, with the provisions each obligation rests on, are as follows.

3. Expert insights

Insight 1: a fixed 20-day gap separates publication from entry into force. The SECOND provision of 0631-ARSA-2023 and Article 29 of the technovigilance regulation both state that the rule enters into force 20 days after publication, but the publication dates differ: 2024-09-21 for the former and 2025-09-29 for the latter. The effect for companies is that the switching points between the old and new regimes differ: registration obligations run under the new rules from the fourth quarter of 2024, while the reporting clock for vigilance only starts under the new rules in the fourth quarter of 2025. Compliance calendars must mark the two dates separately and must not use a single day for both.

Insight 2: fees and deadlines are not in the main regulation. The 93 articles of the main regulation only settle whether an authorisation is needed, what documents it requires and how long it lasts; processing deadlines and service fees sit in Acuerdo 012-2020 (11 categories of matters of the Devices Directorate) and Acuerdo 003-2021 (establishment licences, priced in fractions of the minimum average wage, with separate on-site and online scales). The GRZAN regulatory team notes that these two resolutions apply to specific matters, not to product risk classes, so any citation must name the category of matter.

Insight 3: the main fee table of Acuerdo 012-2020 is an image with no text layer. When checking the official PDF, we found that the fee tables of provisions SECOND to TENTH are laid out as images, so the specific amounts cannot be verified from the text layer; only provision SEVENTH (special authorisation for non-governmental organisations) can be read as 5 working days and 1/9 of the minimum average wage. This volume therefore gives no specific official-fee figures and states only the verifiable pricing basis. This is the most important no-numbers decision of this series.

Insight 4: the supplementary order of Article 89 is the backstop in disputes. Where the regulation does not expressly provide, the order of application is international treaties, the Health Code, the Civil Procedure Code, the General Law of Public Administration, the Administrative Procedures Law and general principles of law, with ARSA technical provisions last. The practical value for applicants is that procedural remedies can be argued from the Administrative Procedures Law, without needing to find an answer inside internal ARSA guidance.

Insight 5: Article 93 gave ARSA a 180-day window for supporting legislation. Article 93 of the main regulation requires ARSA to issue agreements, procedures, manuals, guides and internal norms within 180 days of publication. The texts relied on in this volume are settled, but supporting detail is still landing progressively; content must be rechecked quarterly, especially the format versions of document lists, since Article 32 repeatedly requires forms established by ARSA.

4. Practical recommendations

• Build a four-layer source table for this market and tag every obligation to a specific document and article, avoiding mixed citations.
• Mark the two switching points separately on the compliance calendar: the fourth quarter of 2024 (main device regulation) and the fourth quarter of 2025 (technovigilance regulation).
• When citing fees, write only that pricing is in fractions of the minimum average wage as published by ARSA for the period, and never state specific amounts.
• In procedural disputes (deficiencies, deadlines, service of documents), search the Administrative Procedures Law and the General Law of Public Administration first, not only internal ARSA guidance.
• Recheck the Acuerdos and Reglamentos Nacionales sections of the ARSA legal library quarterly, focusing on new format versions.
• Wherever a document list mentions a form established by ARSA, confirm the current version number with the counter window before filing.

5. Verification checklist

• □ A four-layer source table exists and every obligation traces to a document and article
• □ The compliance calendar marks the 2024 and 2025 switching points separately
• □ Quotations and budget documents contain no specific official-fee figures without an official source
• □ Cited fee bases come from Acuerdo 003-2021 or 012-2020, not from the main regulation
• □ The search list for procedural disputes includes the Administrative Procedures Law and the General Law of Public Administration
• □ All ARSA-form items in document lists have had their current version number confirmed

Regulatory information verified as of 2026-10-29.

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com