Medical Samples and Labelling Under Article 85

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, provides in Article 85 that devices distributed as medical samples or as free samples for promotional purposes must carry labels entirely identical to the label approved under the current sanitary authorisation, and must state Muestra Médica: Prohibida su Venta (medical sample: sale prohibited) on the primary and secondary labels, in a clearly legible position visible to the user. The final sentence of the provision sets the key boundary: all medical samples that are not exempt from registration must undergo risk classification and sanitary registration. The GRZAN regulatory team notes: this provision removes free samples entirely from circulation — free of charge does not mean free of authorisation, nor free of labelling requirements. Together with Article 33, which lists advertising among the acts requiring authorisation, it forms a complete set of constraints on marketing activities.

2. Legal basis

The table below maps the provisions relevant to medical samples to their key points.

3. Expert insights

Insight 1: the first principle of sample labelling is identity with the authorisation. The first sentence of Article 85 requires the sample label to be entirely identical (idéntica) to the label approved under the current sanitary authorisation. Samples therefore cannot use simplified labels, trial-pack labels, or presentation wording different from the market version — any difference would conflict with the 18 primary-label items and the 11 complementary-label items of Article 84.

Insight 2: the sale-prohibition marking must appear on both label levels. The provision requires the marking on the primary and secondary labels simultaneously, clearly legible and in a position visible to the user. Affixing it only to the outer carton does not comply. When planning samples, this step must be arranged at the packaging design stage, not added ad hoc before shipment.

Insight 3: the final sentence of Article 85 pulls samples back onto the registration track. The provision states that medical samples not exempt from registration must undergo risk classification and sanitary registration. Together with Article 33, which makes advertising an act requiring authorisation, and Article 77, which imposes seven controls on advertising content, a complete chain emerges: samples must be registered, labels must be identical, the prohibition must be marked, and promotion must not overstep.

Insight 4: registration-exempt products are the only exception. The exception in the final sentence of Article 85 is no sean exonerados — that is, products holding a registration exemption authorisation under Article 53. Samples of such products are not bound by the classification and registration requirement, but they must still observe label identity and the sale-prohibition marking. The judgment rests equally on the classification conclusions of the final paragraph of Article 25 and Article 28.

Insight 5: control of sample flow is the follow-up risk point. Article 10, item 2, requires the establishment’s technical manager to ensure that medical samples, donations or property of any public institution are not sold. This provision pushes sample-control responsibility onto a specific role; combined with the sale-prohibition marking of Article 85, companies must keep a sample distribution ledger traceable to each recipient, ready for the supervision and inspection of Articles 78 to 82.

4. Practical recommendations

• Compare the sample label item by item against the authorised label; do not use simplified or trial-pack versions.
• Plan the sale-prohibition marking on the primary and secondary labels at the packaging design stage, not as a late addition.
• Bring samples into the registration plan: samples of non-exempt products must also be classified and registered first.
• Keep label identity and the sale-prohibition marking for samples of registration-exempt products as well.
• Keep a sample distribution ledger traceable to each recipient, ready for supervision and inspection.
• Write sample-control duties into the job description of the establishment’s technical manager (per Article 10, item 2).

5. Verification checklist

• □ The sample label has been compared item by item with the authorised label
• □ Both the primary and secondary labels carry the sale-prohibition wording in a visible position
• □ Samples of non-exempt products have completed classification and registration
• □ Samples of exempt products still carry identical labels and the sale-prohibition marking
• □ A traceable sample distribution ledger is in place
• □ The technical manager’s job description includes sample-control duties

Related reading: [Article 26 — Primary and complementary labels](/honduras-medical-device-registration/labelling-primary-and-complementary/) | [Article 48 — The seven advertising controls and four prohibitions](/honduras-medical-device-registration/advertising-rules-article-77/) | [Article 10 — Other devices of sanitary interest](/honduras-medical-device-registration/other-devices-of-sanitary-interest/)

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