Other Devices of Sanitary Interest

1. Key takeaways

The final paragraph of Article 25 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, establishes an independent category of other devices of sanitary interest (otros dispositivos de interés sanitario): devices that, by their nature, their own characteristics and their use, are not considered to require an ARSA sanitary registration because they do not fall within a risk class, but that remain of sanitary interest and therefore require the corresponding sanitary authorisation before import, storage, distribution and sale. The provision lists 3 categories: 1 items used for the quality control of food and water for human consumption; 2 devices used for the quality control of water in microbiological, clinical, physicochemical and pharmaceutical laboratories; 3 devices used only for research and forensic purposes. Article 54 brings these categories under import permits, and Article 55 sets two document sets, RUIF and NTDM, in sections I and II. The GRZAN regulatory team notes that such products are not registered but still require authorisation: not being a device does not mean no paperwork, which is the most common misjudgement in this market.

• The only test for the category is that the product does not fall within a risk class.
• RUIF authorisations last 1 year; NTDM authorisations last 6 months or 1 year depending on the service fee paid, and each authorisation may cover up to 5 product categories.
• Labels must state the restriction of use, for example uso exclusivo para investigación y forense.
• Products containing controlled substances still need an import permit issued by the DNPF.

2. Legal basis

The provisions on this category and its two authorisation routes are the following.

3. Expert insights

Insight 1: not falling within a risk class is the only test for the category. The final paragraph of Article 25 states that these products are not considered devices requiring registration because they do not fall within the prescribed risk classes. The order of judgement is therefore: first ask whether the product falls within Clase I to III, and only if the answer is no does it enter this category. Conversely, if ARSA finds at classification that the product does fall within a risk class, registration is mandatory, and RUIF cannot be sought on the ground of research use.

Insight 2: the authorisation structure of RUIF and NTDM differs from product registration. Sections I and II of Article 55 both state that each authorisation may cover up to 5 product categories, with validity of 1 year (RUIF) and 6 months or 1 year (NTDM, depending on the service fee paid), and renewals may be requested at any time before expiry. Compared with the 5-year term of sanitary registration, these authorisations are high-frequency, short-cycle and managed by batch, and they need a renewal calendar of their own.

Insight 3: labels must state the restriction of use. Article 55 section I item 5 requires the label to state the appropriate restriction of use, for example research and forensic use only, or another appropriate restrictive statement. This is a verifiable hard requirement, of the same kind as the no-sale marking for samples under Article 85: the label removes the product from commercial circulation.

Insight 4: controlled substances still pass through the DNPF. Article 32 item 11 and Article 75 item 8 both require that where a product contains a substance regulated by ARSA, an import permit for controlled substances issued by the DNPF must additionally be submitted. Laboratory reagents and forensic products often contain such substances, so DNPF approval must be treated as the critical path in scheduling.

Insight 5: the modification rules share one logic with product registration. The modification list of Article 55 section III is identical to Article 52 (12 categories: company name, validity period, storage conditions, distributor, specifications, legal representative, commercial presentation, chemical composition, discontinuation of an authorised specification, product holder, manufacturer and country of origin, and registering company), and the authorisation keeps the same number and validity after approval. For change management of these products, the internal template for registration modifications can be reused directly.

4. Practical recommendations

• Fix the order of judgement: confirm first that the product does not fall within Clase I to III, and only then take the RUIF or NTDM route.
• Build separate renewal calendars for RUIF (1 year) and NTDM (6 months or 1 year), and do not reuse the 5-year registration cycle.
• File each authorisation with up to 5 product categories bundled, keeping the use of the batch consistent.
• State the restriction of use on the label, for example research and forensic use only, and keep the approved label draft on file.
• Place the DNPF permit on the critical path for products containing controlled substances.
• Reuse the internal template of the 12-category list of Article 52 for change management, checking the rules that preserve the number and validity period.

5. Verification checklist

• □ It has been confirmed with written grounds that the product does not fall within Clase I to III
• □ Renewal calendars for RUIF and NTDM have been set up separately
• □ No authorisation exceeds 5 product categories, and the use within each batch is consistent
• □ Labels state the restriction of use and the label drafts are retained
• □ DNPF permits for products with controlled substances are obtained or scheduled
• □ Change management reuses the 12-category template of Article 52

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