Scope: Fifteen Regulated Activities

1. Key takeaways

Article 2 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, defines the scope of application as being of general interest and covers natural or legal persons engaged in 15 categories of activities (whether public or private): manufacture, upgrading (repotenciación), repair, repackaging (acondicionamiento), import, export, storage, transport, distribution, rental (alquiler), lending (comodato), sale, research, advertising, and maintenance services, together with any other related activity; it also covers the technovigilance activities carried out by ARSA. Article 33 separately lists import, repackaging, export, repair, storage, transport, distribution, sale, rental, lending and advertising, 11 categories in all, as acts that require a valid sanitary authorisation first.

• Article 2 governs persons and Article 33 governs acts; read together, they mean that exporters and repairers also need authorisation.
• Rental and lending are regulated acts, so free placements, loaners and trial units fall within the authorisation regime.
• Advertising requires prior authorisation, and Article 77 adds 7 controls and 4 prohibitions for publicity.
• The closing phrase of Article 2, y/o cualquier otra actividad relacionada, is an open backstop that lets ARSA bring new business models into scope.

2. Legal basis

The following provisions govern the scope of application and the requirement of prior authorisation.

3. Expert insights

Insight 1: Article 2 governs persons and Article 33 governs acts, and the two must be read together. Traders that only export often assume that export requires no registration, but Article 33 expressly lists exportación among the acts requiring prior authorisation, and Article 34 attaches a prohibition to all of them. For Honduran entities handling transit and re-export, this is a direct compliance point.

Insight 2: rental and lending are listed separately. Article 33 names alquiler (rental) and comodato (lending) side by side as regulated acts. This has a large effect on placement models: free placements, rental placements and trial placements all fall within the authorisation regime, and there is no space in which a placement is not a sale merely because no money changes hands. Placement agreements and the scope of the authorisation must be designed together.

Insight 3: advertising is an act requiring prior authorisation. The last item of Article 33 is publicidad, and Article 77 adds 7 controls and 4 prohibitions for advertising. The practical meaning is that an unregistered product cannot even run warm-up publicity, and promotional content must not exceed the scope of the authorisation or the indication information submitted by the registration holder. Marketing schedules must be bound to the registration timetable.

Insight 4: the phrase y/o cualquier otra actividad relacionada is an open backstop. Article 2 adds this sentence after the 15 listed activities, leaving an interface for ARSA to bring new business models into regulation. The effect for companies is that when a new form of business appears, for example remote servicing or devices as a service, it cannot be presumed unregulated merely because it is not in the list; the first step is to request a classification certificate under Article 28.

Insight 5: technovigilance activity itself is within the scope of application. The final sentence of Article 2 brings the technovigilance activities of ARSA into scope, in line with Articles 78 and 79. This explains why vigilance duties could be regulated by a separate ARSA instrument (Acuerdo No. 0185-ARSA-2025): its normative basis is granted by the same main regulation, so no higher law needed to be found.

4. Practical recommendations

• Inventory the activities the company actually performs against the 15 categories of Article 2, and use that activity list as the basis for the licence application scope.
• Bring export and repair operations into authorisation planning; do not exclude them from compliance on the ground that goods only leave the country.
• For placement operations (rental, lending, trials, loans), confirm before signing agreements that the authorisation covers the relevant acts.
• Bind marketing schedules to registration progress, and run no form of product publicity before authorisation is granted.
• When a new business model appears, request a classification certificate under Article 28 first and start operations only after a written conclusion.
• Match the activity scope of the licence application word for word to the Article 2 list; avoid a vague description such as device-related business.

5. Verification checklist

• □ The company activity inventory has been completed against the 15 categories of Article 2
• □ Export and repair operations are included in authorisation planning
• □ Placement agreements confirm that the authorisation covers rental or lending
• □ Marketing schedules are bound to registration progress
• □ New business models have obtained a classification conclusion under Article 28
• □ The activity scope wording of the licence application matches the Article 2 list

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