Semiannual Report and Vigilance Liaison

1. Key takeaways

Two obligations within tecnovigilancia do not disappear simply because nothing has gone wrong: the designation and annual update of the tecnovigilancia liaison officer (enlace de tecnovigilancia), and the semiannual report. Article 11 of Acuerdo No. 0185-ARSA-2025 requires registration holders, manufacturers, importers, distributors, sellers, healthcare providers, independent professionals and other relevant parties to designate and register a liaison officer with the CNTV, together with an assistant (auxiliar); the registration must be updated annually; and where the liaison officer is replaced, the new officer must be registered within one year. Article 20 requires a consolidated semiannual report: the January report covers 1 July to 31 December, the July report covers 1 January to 30 June, and both must be submitted within the first 10 business days of the respective month through the online procedures and forms enabled by the CNTV; for a period with no events, a zero report must still be submitted, accompanied by a plan or report on activities promoting the reporting of adverse events.

2. Legal basis

The table below consolidates the liaison officer requirements and reporting obligations of Acuerdo No. 0185-ARSA-2025, together with the traceability provisions of Acuerdo No. 0631-ARSA-2023 on which the vigilance data rest.

3. Expert insights

Insight 1: the liaison position is a two-person establishment. Article 11 requires that when the liaison officer is designated, an auxiliar (assistant) must be registered at the same time. This is not an option but a registration requirement: a vigilance function staffed by a single person is formally incomplete.

Insight 2: the liaison officer must meet a professional threshold. Article 12, item 1 requires the liaison officer to be a health professional and lists acceptable backgrounds — chemistry, medicine, pharmacy, biomedical engineering, nursing and the like — commensurate with the nature of the establishment represented. Handing the vigilance function to purely administrative staff does not meet the perfil profesional adecuado the provision demands.

Insight 3: the reporting periods are staggered. Article 20 maps the report submitted in January to 1 July to 31 December of the previous year, and the report submitted in July to 1 January to 30 June of the same year. This differs from the habit, common in many companies, of aggregating by calendar year; data must be cut strictly along the periods defined in the provision.

Insight 4: a zero report is not an exemption, and it carries an extra deliverable. The final paragraph of Article 20 provides that where no events occurred during the period, a reporte sin incidencias must be submitted together with a plan or report on activities carried out to promote event reporting. In other words, even a zero-report period requires evidence that events are being actively collected.

Insight 5: the vigilance system shares one data foundation with the traceability requirements of 0631-ARSA-2023. Article 11, item 2 of 0631 requires establishments to keep electronic distribution records, and Article 3, Section II defines trazabilidad as the ability to identify the origin, movement and location of a specific unit or batch or serial number; Article 12, item 2 of 0185 then requires the vigilance registry system to guarantee integrity, accuracy, reliability, confidentiality, traceability and tracking. The data source of both systems is in fact the same batch-level distribution record.

4. Practical recommendations

• Register under the two-person configuration of liaison officer plus assistant, and perform the annual update in the same month every year (Article 11).
• Complete registration of the new officer within one year of a change, and preserve the outgoing officer’s access to historical records during the handover period.
• Select liaison officers with a health professional background and keep degree and experience documents on file for inspection (Article 12, item 1).
• Fix the first 10 business days of January and July as standing delivery milestones, and cut the data along the two periods of 1 July–31 December and 1 January–30 June.
• During zero-report periods, submit the plan or report on activities promoting reporting alongside the report itself — do not file an empty form alone.
• Build batch-level distribution records as a single data source serving both the distribution records of Article 11 of 0631 and the vigilance registry system of Article 12 of 0185.

5. Verification checklist

• □ The vigilance liaison officer and assistant have been registered with the CNTV
• □ The annual update date has been set as a recurring reminder
• □ The within-one-year registration mechanism for replacement officers has been written into HR procedures
• □ Proof of the liaison officer’s health professional background is on file
• □ The January and July milestones (first 10 business days) for the semiannual report are in the calendar
• □ The reporting periods (1 July–31 December and 1 January–30 June) are aligned with the data systems
• □ Templates for the zero report and the plan on activities promoting reporting are ready

Related reading: [Article 47 — Quality control sampling and cost bearing](/honduras-medical-device-registration/quality-control-sampling-and-costs/) | [Article 45 — Tecnovigilancia rules and the 72-hour clock](/honduras-medical-device-registration/tecnovigilancia-acuerdo-0185-2025/) | [Article 11 — Sanitary authorisation required before market entry](/honduras-medical-device-registration/sanitary-authorisation-required-before-import/)

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