Honduras Regulatory Timeline and the 180-Day Window

1. Key takeaways

The instruments of Honduras’s current device regulatory framework appeared in the following order. Decreto Ejecutivo PCM-032-2017 (signed 2017-04-28, published 2017-05-19; amended by PCM-013-2020 in Articles 1, 4, 6, 7 and 10) created ARSA. Decreto No. 7-2021 (La Gaceta No. 35,626, 2021-06-12) confirmed its creation by statute and set out 10 functions. Acuerdo No. 012-2020 (La Gaceta No. 35,299, 2020-06-30) set the completion deadlines and service fees for 11 categories of matters. Acuerdo No. 003-2021 (La Gaceta No. 35,552, 2021-03-23) set the fee rates for licences and transport permits. Acuerdo No. 0631-ARSA-2023 (signed 2023-12-28, published in La Gaceta No. 36,646 on 2024-09-21, containing 93 articles, with item SEGUNDO providing entry into force 20 days after publication). Acuerdo No. 0185-ARSA-2025 (La Gaceta No. 36,954, 2025-09-29, containing 29 articles, with Article 29 providing entry into force 20 days after publication). Article 93 additionally gives ARSA 180 days to issue the protocols, procedures, manuals, guides, criteria and other internal norms arising from the regulation.

2. Legal basis

The table below consolidates the six legal instruments of the framework, their publication data and the clauses that matter most for compliance planning.

3. Expert insights

Insight 1: ARSA was created first by executive action and only later by statute. PCM-032-2017 created ARSA by executive decree; four years later Decreto No. 7-2021 confirmed the creation by statute (Article 1), established the Comisionado Presidente (Article 2), listed 10 functions (Article 7) and provided entry into force on publication (Article 15). This sequence explains why the 2020 fee instrument predates the 2021 organisational statute, and why the fee instruments and the new regulation sit at staggered layers.

Insight 2: signature and publication of the main device regulation are about 9 months apart. 0631-ARSA-2023 is dated 28 December 2023 but was published on 21 September 2024, and item SEGUNDO provides entry into force 20 days after publication. A multinational that tracks only the signature date will misjudge when the rules apply — in Honduras, entry into force runs from the date of publication in the official gazette.

Insight 3: the 180-day window of Article 93 means accompanying instruments are still rolling out. The article requires ARSA to issue protocols, procedures, manuals, guides, criteria and internal norms within 180 days of the regulation’s publication. Application formats, form versions and parts of the operational practice may therefore keep changing; project schedules should hold a buffer for format changes.

Insight 4: in 2025, tecnovigilancia moved from principle to clock. 0631-ARSA-2023 established the CNTV and vigilance principles only in Articles 78 and 79, whereas 0185-ARSA-2025 delivers four enforceable clocks — 72 hours, 30 days, 5 days and the semiannual report — entering into force 20 days after publication. This is the most direct new compliance burden of the past two years.

Insight 5: clinical trials run through three stages: ethical evaluation, ARSA approval and the site permit. Article 86 provides that study protocols are evaluated and approved by the Comité de Ética en Investigación Biomédica (CEIB) of the Universidad Nacional Autónoma de Honduras, with ARSA able, where appropriate, to consider other registered and recognised national medical ethics committees; the sanitary permit for the trial site is issued by ARSA; the principal investigator is responsible for the management, storage and final disposal of investigational products; and costs arising from adverse events are borne by the trial site and its principal investigator.

4. Practical recommendations

• Base schedules on the gazette publication date: track the La Gaceta publication date, not the signature date of the instrument.
• Put the accompanying instruments of Article 93 on the monitoring list: check periodically whether ARSA has issued new protocols, manuals, guides or form versions.
• Review the fee instruments once a year: focus on whether 003-2021 has been updated to cover the 4-year and 6-year licences under 0631-ARSA-2023, and whether the fee tables of 012-2020 have been transcribed into text.
• Rebuild the vigilance system around the four clocks of 0185-ARSA-2025 rather than carrying over internal processes predating 2025.
• Schedule clinical trial projects in three stages: CEIB ethical evaluation, then ARSA research authorisation, then the trial-site sanitary permit, and reserve arrangements for the principal investigator’s duties over investigational product management and disposal.
• Maintain a legal-source register: fix the publication dates and entry-into-force clauses of the six instruments — PCM-032-2017, Decreto 7-2021, 012-2020, 003-2021, 0631-ARSA-2023 and 0185-ARSA-2025 — into internal procedures.

5. Verification checklist

• □ Publication dates and entry-into-force clauses of the six legal instruments are in the register
• □ Project schedules uniformly adopt the gazette publication date as the counting basis
• □ A monitoring list for the accompanying instruments of Article 93 has been established
• □ An annual review mechanism for the fee instruments has been established
• □ Vigilance processes have been rebuilt around the four clocks of 0185-ARSA-2025
• □ The three-stage path of CEIB, ARSA and site permit is defined for clinical trial projects

Related reading: [Article 50 — GRZAN device registration services in Honduras](/honduras-medical-device-registration/grzan-honduras-registration-services/) | [Article 41 — Twelve categories of post-registration changes](/honduras-medical-device-registration/post-registration-changes-twelve-types/) | [Article 02 — The four layers of legal sources](/honduras-medical-device-registration/honduras-medical-device-legal-framework/)

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 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