Requirements for Medical Disinfectants and Antiseptics

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, includes in Article 25, item 8, disinfecting, antiseptic, skin-filling, lubricating and decongestant solutions without active ingredients and with only topical action among the intended uses of a device; and Article 43, Section 3, sets out seven additional items for medical disinfectant and antiseptic products (productos desinfectantes y antisépticos de uso médico-hospitalario): 1 the insert; 2 technical documentation supporting shelf life or stability; 3 storage and transport conditions; 4 the qualitative and quantitative formulation by measurement unit or dosage; 5 the sterilisation certificate (where applicable); 6 the container-closure technical document (where applicable); 7 the product effectiveness validation report (informe de validación de la efectividad del producto). The GRZAN regulatory team notes: item 7 is the core of this product category — disinfectant or antiseptic claims must be backed by effectiveness validation, following the same evidentiary logic as the ISO document required for the sterile symbol under Article 84, Section 1.

2. Legal basis

The table below maps each requirement for disinfectant and antiseptic products to its provision and key point.

3. Expert insights

Insight 1: Article 25, item 8, is the qualifying gateway for this product category. The provision writes disinfecting, antiseptic, skin-filling, lubricating and decongestant solutions without active ingredients and with only topical action into one of the eight intended uses of a device. The key test is that two conditions hold simultaneously: no active ingredients and topical action only. Disinfectant products containing active ingredients fall outside this list and should be assessed along the medicines route (the referral mechanism of Article 48 may serve as a reference).

Insight 2: the effectiveness validation report is the core evidence for this category. Article 43, Section 3 g), requires the informe de validación de la efectividad del producto. This document supports precisely the disinfectant or antiseptic claims on the label, and it operates under the same mechanism as Article 43, item 13 (the sterile symbol requires ISO documentation): whatever is claimed must be evidenced.

Insight 3: the container-closure technical document is frequently missed. Article 43, Section 3 f), requires the documento técnico del envase-cierre (where applicable). For liquid disinfectant products, the compatibility of the container and closure directly affects the stability and shelf-life conclusions; it pairs with the stability document under item 2 and should be prepared together.

Insight 4: the sterilisation certificate is a conditional document. Article 43, Section 3 e), is marked cuando aplique — when applicable — and is needed only where the product claims sterility. This matches the trigger of Article 43, item 13: the word sterile on the label triggers both the sterilisation certificate and the ISO conformity document.

Insight 5: the change-of-chemical-composition chain is the longest. Article 52, item 3 h), requires for a change of chemical composition the product holder’s declaration with apostille or authentication, the technical datasheet reflecting the change, the safety data sheet reflecting the change, the insert reflecting the change, and the IFU reflecting the change — five documents in total. This is the heaviest documentation load among the twelve types of change, and disinfectant and antiseptic products adjusting formulations should reserve lead time for the longest chain.

4. Practical recommendations

• Test the product against the two conditions of no active ingredients plus topical action only to determine whether it falls under Article 25, item 8.
• Prepare an effectiveness validation report backing each disinfectant or antiseptic claim on the label.
• Prepare the container-closure technical document together with the stability document for liquid disinfectant products.
• Where the label claims sterility, prepare the sterilisation certificate and the ISO conformity document together.
• Reserve lead time for the five-document chain of Article 52, item 3 h), when adjusting formulations.
• Build the seven supplements of this category into a separate checklist managed alongside the sixteen items of Article 43.

5. Verification checklist

• □ The product has been assessed against no active ingredients plus topical action only
• □ The effectiveness validation report is in place
• □ Liquid products have the container-closure technical document and stability document in place
• □ Sterile-claim products have the sterilisation certificate and ISO document in place
• □ Lead time has been reserved for the five-document change chain
• □ A separate checklist covers the seven supplements of this category

Related reading: [Article 21 — The sixteen Class I dossier items](/honduras-medical-device-registration/class-i-dossier-sixteen-requirements/) | [Article 26 — Primary and complementary labels](/honduras-medical-device-registration/labelling-primary-and-complementary/) | [Article 41 — The twelve types of post-registration change](/honduras-medical-device-registration/post-registration-changes-twelve-types/)

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