Advertising Rules under Article 77

1. Key takeaways

The premise for promoting a device in Honduras is holding a valid sanitary authorisation. Article 77 of Acuerdo No. 0631-ARSA-2023 provides that devices with a valid authorisation may be advertised to differentiate them in the market, in order to promote their commercialisation, prescription, dispensing, supply, purchase or use, but the advertising must be consistent with their characteristics and specifications and with the conditions of the authorisation granted by ARSA. It applies seven basic regulatory controls: not targeting unsuitable audiences; making only claims supported by scientific evidence; covering only devices already authorised by ARSA for marketing; consistency with the indications and other information submitted by the holder in the authorisation; use of Spanish; absence of false or misleading claims; and compliance with the other requirements of the target market. The provision also lists four absolute prohibitions: not attributing qualities of prevention, treatment or rehabilitation beyond the device’s intended purpose; not expressly or implicitly suggesting ingredients, components or properties the device does not contain; not using exaggerated techniques to deceive consumers; and not exploiting public fear or anxiety. In addition, under Article 33, advertising itself is one of the 11 categories of conduct that require prior authorisation.

2. Legal basis

The table below consolidates the advertising provisions of Article 77 and the adjacent provisions that define who may claim what, and in which language.

3. Expert insights

Insight 1: the right to advertise flows from the registration, not from a separate permit. Article 77 confines advertising to devices que posean autorización sanitaria vigente — that hold a valid sanitary authorisation — and Article 33 lists advertising among the 11 categories of conduct requiring prior authorisation. For a product without a registration certificate, even warm-up publicity falls within the prohibition.

Insight 2: the scope of claims is locked to the indications declared at authorisation. Item 4 requires the advertising to be consistent with the indications and other information submitted by the holder in the authorisation, and Article 43, item 1, l) makes clear that instructions and indications are defined by the product owner (titular). This means the promotional message cannot exceed the dossier: indication language expanded unilaterally by a marketing department is a direct violation.

Insight 3: the mandatory Spanish rule and the labelling rules share one source. Item 5 requires advertising to be in Spanish, the same language policy as Article 85, Section 3 — which requires labels to be in Spanish or accompanied by a translation legalised by the Ministry of Foreign Affairs — extended from compliance documents to communication materials.

Insight 4: prohibition four is a distinctive clause of Latin American advertising regulation. The phrase usar estrategias de publicidad que aprovechen el miedo o la ansiedad de la población — marketing strategies that exploit public fear or anxiety — is expressly banned. For IVDs and home-use devices whose selling points are screening, early detection or serious-disease risk, this clause demands particular attention from marketing teams.

Insight 5: online promotion is expressly covered. Article 77 states incluida la promoción en línea — including online promotion — before listing the controls, placing online campaigns on the same footing as offline materials. Social media, e-commerce product pages and influencer content all sit within the regulatory field of view.

4. Practical recommendations

• Verify before launching: confirm that every model to be promoted has a corresponding valid sanitary authorisation and that the scope of the authorisation covers the intended promotional channel.
• Maintain a claims comparison table: check every line of advertising copy against the indications and information submitted in the authorisation (Article 77, item 4), with sign-off by the regulatory function before release.
• Produce a Spanish version of all external copy, and do not use non-Spanish versions as the launch versions in Honduras (item 5).
• Ban fear- or anxiety-based messaging: for screening and serious-disease risk products, switch to neutral wording (prohibition four).
• Bring online content into the same review process: social media, e-commerce pages and influencer scripts must all pass regulatory review.
• Update promotional materials only after a change is approved: after a change of product owner, manufacturer, specifications or packaging (Article 52), the superseded claims must be withdrawn in step.

5. Verification checklist

• □ The valid authorisation number of every model to be promoted has been checked
• □ The comparison table between advertising copy and the authorised indications has been signed by the regulatory function
• □ The Spanish version has been finalised and adopted as the local launch version
• □ Fear- or anxiety-based messaging has been removed from the copy
• □ Online channels (social media, e-commerce, influencers) have been brought into the regulatory review process
• □ A mechanism for withdrawing and updating promotional materials after registrations and changes 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 47 — Quality control sampling and cost bearing](/honduras-medical-device-registration/quality-control-sampling-and-costs/) | [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