Reclassification and Referral to DNPF

1. Key takeaways

The end point of a modification application is not necessarily an approved modification. Article 48 of Acuerdo No. 0631-ARSA-2023 gives ARSA two powers. When evaluating a modification, ARSA may reclassify the device (reclasificación) according to its level of sanitary risk — the trigger being that three elements, namely specifications, intended purpose or chemical composition, have undergone major changes that may affect sanitary safety — and the consequence may be a corresponding change to the sanitary registration. If the technical evaluation further concludes that the intended purpose of the device now falls within the pharmaceutical sphere, the file is referred to the Dirección Nacional de Productos Farmacéuticos y Otros del Ramo de Interés Sanitario (DNPF); the applicant must then proceed under the pharmaceutical regulation, and the referral must be notified to the applicant. The practical lesson is that Article 48 offers two exits that both hang on the single entrance of modification review, while modifications themselves are constrained by the twelve-category list of Article 52: once a product undergoes a substantive change, what lies ahead is not merely document preparation but potentially a change of regulatory pathway.

2. Legal basis

The table below consolidates the provisions governing reclassification during modification review and the referral mechanism to the pharmaceutical directorate, together with the risk-classification framework that both mechanisms draw upon.

3. Expert insights

Insight 1: reclassification is not a standalone procedure but the outcome of modification review. Article 48 opens with the words al evaluar las modificaciones — when evaluating modifications. In other words, a company will never receive a reclassification application form; instead, after submitting a modification under Article 52 (especially e) specifications or h) chemical composition), ARSA determines of its own motion whether the risk class must move upward.

Insight 2: the axis of determination matches Article 29 exactly. Article 29 establishes intended purpose as the primary axis, with reference to anatomical site, duration of contact, degree of invasiveness and whether the device releases medicines or energy. The trigger elements of Article 48 are precisely specifications, finalidad (intended purpose) and chemical composition. The two provisions are the same logic applied at initial classification and at subsequent adjustment.

Insight 3: referral to the DNPF is a change of route, not a rejection. The wording of the provision is se remitirá a la DNPF, and the applicant must then satisfy the requirements of the pharmaceutical regulation. For drug-device combinations, drug-coated products or products whose pharmacological action is enhanced by a reformulation, this means switching from a device dossier to a pharmaceutical dossier, with entirely different timelines and materials — project budgets must be prepared along both paths separately.

Insight 4: the referral must be notified, which is a procedural safeguard. The final sentence of Article 48, Dicha remisión será notificada al peticionario, makes notification an obligation. Only after receiving the referral notice does the company become obliged to supplement its file under the pharmaceutical regulation; before that, it need not switch pathways on its own initiative.

Insight 5: the referral mechanism and the device definition of Article 25 mark the same boundary. Article 25 requires that the principal intended action of a device is not achieved by pharmacological, immunological or metabolic means (medicinal, immunological or metabolic action being only ancillary). Once a modified product crosses this line it no longer belongs to the device category, and the referral mechanism of Article 48 is the enforcement device for that boundary.

4. Practical recommendations

• Run a boundary self-assessment before modifying: determine whether the change touches any of the three elements — specifications, intended purpose or chemical composition — and whether it may affect sanitary safety (Article 48).
• Where medicinal ingredients, drug coatings or adjustments to the mechanism of action are involved, prepare contingency plans and budgets for the pharmaceutical path in advance, rather than scheduling on the device path alone.
• When changing specifications (item e)) or composition (item h)), review each of the four reference factors of Article 29 — anatomical site, duration of contact, degree of invasiveness, and release of medicines or energy — and anticipate whether the class will move upward.
• After an upward reclassification, prepare the additional documents for the new class in parallel: ISO 13485 for Class IIA (Article 44), device-specific ISO certification for Class IIB (Article 45), and the four test items and finished-product analysis certificate for Class III (Article 46).
• Upon receiving the DNPF referral notice, switch immediately to the document list of the pharmaceutical regulation and treat the date of the notice as the starting point of the new pathway.
• Retain the initial classification report (Article 31) and all modification approval documents as traceable evidence of how the risk class has evolved.

5. Verification checklist

• □ The intended change has been self-assessed against the three Article 48 elements (specifications, intended purpose, composition)
• □ The four reference factors of Article 29 have been reviewed one by one and the risk of an upward reclassification evaluated
• □ The list of additional documents after an upward reclassification (Articles 44, 45 and 46) has been prepared
• □ Contingency plans for the pharmaceutical path exist for drug-containing or pharmacologically enhanced cases
• □ A responsible person has been designated for receiving and responding to DNPF referral notices
• □ The initial classification report and all modification approvals have been archived

Related reading: [Article 43 — Eight refusal grounds](/honduras-medical-device-registration/refusal-grounds-article-87/) | [Article 41 — Twelve categories of post-registration changes](/honduras-medical-device-registration/post-registration-changes-twelve-types/) | [Article 09 — Four risk classes and the Article 29 axis](/honduras-medical-device-registration/four-risk-classes-i-iia-iib-iii/)

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