Establishment Types and the Technical Manager

1. Key takeaways

Article 8 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, divides establishments engaged in the activities of Article 2 into 9 categories: manufacturers or producers, importers, storage facilities, repackagers, upgraders (potenciadores), distributors, sellers, maintenance service providers, and clinical trial sites for devices; a single establishment may carry out one or more of these activities. Article 9 requires all establishments to hold a valid sanitary licence issued by ARSA, displayed in a visible place, and to have a technical manager (profesional técnico responsable) suited to the nature of their devices. It also lists 3 categories exempt from the technical manager requirement: 1 devices exempt from sanitary registration, 2 devices of risk class Clase I, and 3 other devices and risk classes determined by ARSA. Article 10 lists 8 functions for the post. The GRZAN regulatory team notes that the exemption is granted by product, not by company: a company handling both Clase I and Clase III products still needs a technical manager.

• The 9 establishment categories determine how the activity scope of the licence should be written.
• Exemption from the technical manager is assessed product by product at SKU level, not by company size or nature.
• Article 10 item 2 places a hard duty on the technical manager to block non-compliant stock from distribution.
• Article 10 item 7 folds recall cooperation with the DNVFS into the job description.

2. Legal basis

The provisions on establishment types, licensing and the technical manager are the following.

3. Expert insights

Insight 1: the establishment classification decides how the activity scope of the licence is written. Article 8 lists 9 categories, item h of the application form for a new licence under Article 17 asks for the one or more activities to be performed, and Article 20 allows activities to be added by way of modification. The GRZAN regulatory team advises writing all foreseeable activities across the 9 categories in full at first application: adding activities later follows the Article 20 modification procedure with a further fee, which costs more than writing them in at the start.

Insight 2: the three exemptions from the technical manager are assessed product by product. Article 9 is worded as applying when the authorised activities concern the listed devices; it is not an exemption by company size or nature. A company selling both Clase I consumables and Clase III implants must therefore still have a technical manager, while a company handling only products exempt from registration need not. The assessment must be run item by item at product level.

Insight 3: Article 10 item 2 imposes a hard duty on the technical manager. The post must ensure that the establishment does not distribute devices lacking sanitary authorisation, expired, deteriorated, adulterated, falsified, under sanitary alert, seized by ARSA, or held or forfeited in judicial or investigative proceedings, and must not sell medical samples, donations or property of any public institution. This places direct responsibility for stock compliance on a natural person, not an abstract duty at company level.

Insight 4: Article 10 item 7 writes recall cooperation into the job description. The technical manager must coordinate with the vigilance officer on notifications and responses to domestic and foreign alerts, and support recalls by the Dirección Nacional de Vigilancia y Fiscalización Sanitaria (DNVFS). Read with Article 46 (Article 25 of the vigilance regulation requires substandard and falsified devices to be reported within 5 calendar days), this forms a complete post-market chain: detect, notify, recall, document.

Insight 5: Article 10 item 8 reserves an interface with the vigilance regulation. The provision requires that a technical manager who also serves as vigilance officer meet the conditions and functions set in the rules of the technovigilance centre. That regulation is Acuerdo No. 0185-ARSA-2025 (La Gaceta No. 36,954, 2025-09-29), whose Articles 11 and 12 require the vigilance liaison to have a health professional background (chemistry, medicine, pharmacy, biomedical engineering, nursing, among others) and to update the registration annually. One person may hold both posts, but must satisfy both sets of conditions.

4. Practical recommendations

• Write all foreseeable activities across the 9 categories in full at first licence application, avoiding later additions and extra fees.
• Judge each SKU against the three exemptions from the technical manager requirement and record the written conclusion.
• Match the job description of the technical manager to the 8 functions of Article 10 item by item, and keep records of performance.
• Build a blocking mechanism for non-conforming and alert-listed stock, ensuring the technical manager holds a real veto.
• Rehearse recalls and vigilance notifications as one combined process, naming the liaison with the DNVFS.
• Where one person serves as vigilance liaison, check the professional background and annual update requirements of Articles 11 and 12 of Acuerdo 0185-ARSA-2025 at the same time.

5. Verification checklist

• □ The activity scope of the licence application covers all 9 categories of Article 8 in one pass
• □ The three exemptions from the technical manager have been assessed at SKU level
• □ The job description of the technical manager maps to the 8 functions of Article 10
• □ The blocking mechanism for non-conforming and alert-listed stock exists with records
• □ Recall and vigilance notification processes have been rehearsed jointly with a named liaison
• □ Anyone doubling as vigilance liaison meets Articles 11 and 12 of Acuerdo 0185-ARSA-2025

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