GRZAN Honduras Registration Services

1. Key takeaways

GRZAN delivers an end-to-end service chain in Honduras: from the risk classification report (CDM) to sanitary registration, from establishment and transport licences to import authorisations, from label localisation to the build-out of the tecnovigilancia system. Our delivery model is a dual-party structure of foreign product owner plus locally licensed partner: the foreign manufacturer retains rights and responsibilities as the Titular del producto, while a Honduran importer or distributor holding a Licencia Sanitaria acts as the Empresa registrante and carries the registration and traceability obligations, with GRZAN responsible for dossier preparation, submission and full life-cycle maintenance. We cover 4 risk classes (Clase I / IIA / IIB / III), 9 categories of establishment licences, 3 categories of special import authorisations (AEG / AENG / AEP) and donation authorisations, and we handle the 5-year age-limit certificate and identity labelling for refurbished and second-hand biomedical equipment.

2. Legal basis

The table below maps each service line to the provisions of the Honduran framework from which the corresponding obligation or authorisation derives.

3. Expert insights

Insight 1: the dual-party structure puts rights and obligations in the right places. 0631-ARSA-2023 defines the Titular del producto as the legal person holding all legal and intellectual property rights, while the Empresa registrante must state its own sanitary licence number in the application. GRZAN designs the structure accordingly: the foreign manufacturer retains the product owner position, the locally licensed partner carries the registration and traceability duties, and the rights and obligations of both sides are fixed through powers of attorney and agreements.

Insight 2: the three authorisations must proceed in sequence. Sanitary licence (Articles 12–24), then risk classification report (Articles 29–32), then sanitary registration (Articles 43–46). The classification report is valid for 6 months and extendable only once for a further 6 months (Article 31), and registration renewal must begin at least 5 months in advance (Article 35); these two clocks define the tightest feasible project schedule.

Insight 3: official fees are fraction-based and cannot be quoted as fixed foreign-currency amounts. Service fees for licences and matters are calculated in fractions of the Salario Mínimo Promedio (minimum average wage) under Acuerdo 003-2021 and 012-2020, and most fee tables in 012-2020 were published in the official PDF as images with no text layer to verify. GRZAN’s practice is to model the budget in fractions and to treat amounts as final only against the current ARSA payment notice.

Insight 4: tecnovigilancia is a standing obligation added in 2025. 0185-ARSA-2025 introduces 72-hour, 30-day, 5-day and semiannual reporting clocks, and requires a two-person configuration of liaison officer plus assistant with annual registration updates. GRZAN builds the vigilance system for clients and carries out the submission of semiannual and zero reports.

Insight 5: post-registration maintenance is routinely underestimated. Article 52 lists 12 categories of changes; Article 48 allows ARSA to reclassify or refer to the DNPF on the basis of modification review; Articles 87 and 88 set out refusal and cancellation grounds; and the sampling costs of Articles 80–82 fall on the licence holder. GRZAN therefore packages post-registration maintenance as an annual service rather than a one-off project.

4. Practical recommendations

• Run the pathway determination before initiating the project: establish whether the product is a device under Article 25, whether it falls within the other health-related devices of the final paragraph of Article 25, and whether the exemptions of Article 42 or the waivers of Article 53 apply.
• Build the dual-party structure in one pass: settle the Titular and the local registrante together, and sign a single power of attorney covering both registration and the right to file Article 52 modifications.
• Schedule along the three authorisations in sequence, and place the three key milestones — the 6-month classification report, the 5-year registration, and renewal 5 months in advance — into the project Gantt chart.
• Model the budget in fractions and lock the amounts only after obtaining the current ARSA payment notice; do not rely on any fixed amount lacking an official source.
• Negotiate post-market services in one package: liaison officer registration and annual updates, execution of the four reporting clocks, semiannual and zero reports, modification filings and sampling cooperation.
• Manage document versions centrally: technical sheet, safety sheet, insert, IFU and labels must be updated together whenever an Article 52 change occurs, avoiding version conflicts.

5. Verification checklist

• □ Whether the product is a device, its risk class and the applicable pathway have been determined
• □ The dual-party structure of Titular and local registrante has been settled
• □ The power of attorney covers registration and the right to file Article 52 modifications
• □ The schedule of the three authorisations and the three key clocks are in the Gantt chart
• □ Official fees have been modelled in fractions and the current ARSA payment notice obtained
• □ The post-market service package (vigilance, semiannual reports, modifications, sampling cooperation) has been confirmed
• □ A version-management mechanism for technical documents and labels has been established

Related reading: [Article 49 — Regulatory timeline 2020–2026 and the 180-day window](/honduras-medical-device-registration/honduras-regulatory-timeline-and-180-days/) | [Article 01 — Who regulates medical devices in Honduras](/honduras-medical-device-registration/who-regulates-medical-devices-in-honduras/) | [Article 12 — The three authorisations in order](/honduras-medical-device-registration/three-authorisations-in-order/)

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