Tecnovigilancia under Acuerdo No. 0185-ARSA-2025

1. Key takeaways

Honduran tecnovigilancia has moved from principle to clock, and the marker is Acuerdo No. 0185-ARSA-2025, the Reglamento de Tecnovigilancia (La Gaceta No. 36,954, published 2025-09-29, containing 29 articles, with Article 29 providing that it enters into force 20 days after publication). It sets four reporting clocks for companies: serious adverse events must be reported as soon as possible and no later than 3 calendar days (72 hours) from becoming aware (Article 18); non-serious events with a rising incidence rate, after analysis and verification by the liaison officer, within 30 calendar days (Article 19); discovery of substandard or counterfeit devices within 5 calendar days (Article 25); and the semiannual report submitted in the first 10 business days of January and July (Article 20). As for institutional structure, Article 4 establishes the National Tecnovigilancia System (SNTV) and the National Tecnovigilancia Centre (CNTV), and Article 6 places the CNTV under the medical devices directorate (DDM) of ARSA.

2. Legal basis

The table below consolidates the reporting clocks, the event classification and the institutional provisions of Acuerdo No. 0185-ARSA-2025.

3. Expert insights

Insight 1: the four clocks are independent and must not be read as one. The 72-hour clock of Article 18 applies to serious events and starts from becoming aware (desde que se ha tenido conocimiento); the 30-day clock of Article 19 applies to non-serious events and starts after analysis and verification by the liaison officer; the 5-day clock of Article 25 applies to the discovery of substandard or counterfeit devices; and Article 20 is a periodic 10-business-day window. Their starting points, subject matter and submission methods all differ, so companies must run the clocks separately according to the nature of the event.

Insight 2: two of the eight criteria for serious events point directly at documentation and diagnosis. Article 14, item f) includes among serious events indirect harm caused by an erroneous diagnosis or test result from an IVD used according to the manufacturer’s instructions; item h) includes serious deterioration of a patient’s health caused by omissions or defects in the labelling, instructions for use and promotional material. In other words, the correctness of technical documentation is itself an object of vigilance, and a labelling error by an IVD company can directly trigger a 72-hour report.

Insight 3: reporting is not limited to companies. Article 18 makes clear that users or patients, health professionals, and tecnovigilancia liaison officers of the device industry at home and abroad may all report to the CNTV. This means a company’s 72-hour clock may be started externally before the company itself is even aware; an internal mechanism for recovering information from distributors and hospitals is therefore indispensable.

Insight 4: vigilance obligations cover every actor in the chain. Article 8 brings within scope the registration holder, the device product owner, manufacturers, refurbishers, repackagers, importers, exporters, warehousing parties and distributors, as well as entities engaged in rental, lending, transport, sale, research and maintenance, requiring them to establish a vigilance system covering the entire life cycle of the device and to keep records traceable. Article 9 separately imposes four obligations on healthcare providers and independent health professionals.

Insight 5: events during clinical trials are received centrally by the CNTV. Article 21 requires investigational devices to comply with the national clinical research rules; Article 22 assigns the reception, identification, registration, analysis, evaluation and follow-up of adverse events during trials to the CNTV. Together with Article 86 of 0631-ARSA-2023 (ethical evaluation by CEIB of UNAH, approval by ARSA and issuance of the trial-site permit), this creates two parallel regulatory lines during the trial phase.

4. Practical recommendations

• Build an internal decision tree around the four-level classification of Article 13: classify first, start the clock second, so that a serious event is never processed as a non-serious one.
• Engineer the 72 hours as an end-to-end process: awareness at the distributor or hospital end, verification by the liaison officer, use of the ARSA form (Article 12, item 3), submission to the CNTV — with no manual hand-offs in between.
• IVD companies should watch labelling and instructions especially closely: under Article 14, items f) and h), misdiagnosis and documentation defects can both constitute serious events.
• Time substandard and counterfeit discoveries separately: the 5 calendar days of Article 25 are tighter than 30, and the report must contain at least the four items of Article 26 — product name, place of discovery, batch number and product owner or manufacturer, and the grounds for the judgement.
• Bring the external reporting route of Article 18 into the monitoring scope: agree information return deadlines with local distributors and healthcare institutions so that the company’s awareness date is never later than that of the CNTV.
• For clinical trial projects, interface with both the CNTV and CEIB: trial-phase events go to the CNTV under Article 22, while protocols pass ethical evaluation and ARSA approval under Article 86.

5. Verification checklist

• □ The decision tree for the four-level classification of Article 13 has been written into the vigilance SOP
• □ The 72-hour reporting path is open end to end (awareness, verification, ARSA form, submission)
• □ A responsible person has been designated for the analysis and verification step of 30-day non-serious event reports
• □ The four-content template for 5-day substandard or counterfeit reports is ready (Article 26)
• □ The January and July windows (first 10 business days) for the semiannual report are in the calendar
• □ Dual contacts for the CNTV and CEIB have been named for clinical trial projects
• □ The vigilance record system meets the requirements of integrity, accuracy, reliability, confidentiality and traceability (Article 12, item 2)

Related reading: [Article 46 — Semiannual report and vigilance liaison](/honduras-medical-device-registration/semiannual-report-and-vigilance-liaison/) | [Article 49 — Regulatory timeline 2020–2026 and the 180-day window](/honduras-medical-device-registration/honduras-regulatory-timeline-and-180-days/) | [Article 44 — Five cancellation grounds and eight sale prohibitions](/honduras-medical-device-registration/cancellation-grounds-article-88/)

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