Refusal Grounds under Article 87

1. Key takeaways

Article 87 of Acuerdo No. 0631-ARSA-2023 lists eight situations in which sanitary authorisation shall not be granted: the reference scientific literature shows that the device lacks the essential principles of quality and performance; the studies or investigations supporting the application are incomplete or insufficient to demonstrate quality, safety and effectiveness; the submitted documents are found, under the regulations in force, to have been tampered with or falsified (carrying criminal, civil or administrative liability); the authorisation requested duplicates one already issued by ARSA; there exists a health alert issued by an international regulatory authority recommending non-approval or non-listing of the product; the device is not considered to be of sanitary significance; scientific analysis finds the product to be substandard (subestándar) or counterfeit (falsificado); and any other situation ARSA concludes upon after a technical-legal analysis. Running in parallel is the second paragraph of Article 38, which sets out four situations in which marketing authorisation shall not be granted, the first of which extends vigilance to both the national and international levels.

2. Legal basis

The table below consolidates the eight refusal grounds of Article 87, the parallel marketing prohibitions of Article 38, and the supporting framework that underlies them.

3. Expert insights

Insight 1: item 1 turns the essential principles from an aspiration into a threshold. Article 6 lists the five essential principles of the WHO (covering design, risk and service life), and Article 87, item 1 then provides that whenever reference scientific literature shows the device lacks the essential principles of quality and performance, authorisation shall be denied. The essential principles thereby acquire a negative, disqualifying effect.

Insight 2: item 5 transmits foreign regulatory actions directly into Honduras. The trigger is not a failed domestic test but the existence of a health alert issued by an international regulatory authority recommending non-approval or non-listing. This means a single alert from the country of origin or from a stringent authority can block review in Honduras — companies must therefore fold global alert status into their pre-submission self-checks, covering both the country of origin and the stringent markets where the device is already listed.

Insight 3: the adverse consequences of item 3 go beyond the administrative level. The provision states so pena de la responsabilidad penal, civil o administrativa — that is, beyond non-authorisation, document falsification may also give rise to criminal, civil and administrative liability. It is the only one of the eight grounds that expressly names all three categories of liability.

Insight 4: item 4 echoes Article 41, closing the anti-duplication loop. Article 41 prohibits the same natural or legal person from applying repeatedly for the same device; Article 87, item 4 then provides, on the approval side, that duplication results in refusal. Together the two provisions explain why Article 40, when allowing multiple holders to coexist, particularly emphasises the premise that no exclusive distribution exists.

Insight 5: item 8 is an open catch-all. The phrase otros que la ARSA considere posterior al análisis técnico-legal reserves the conclusions of technical-legal analysis as a basis for granting or refusing authorisation. This is why, in addition to the dossier itself, records of technical communications with ARSA are equally worth archiving: they may become the reference point against which the authority weighs an application it is otherwise free to refuse under this open clause.

4. Practical recommendations

• Run a global alert self-check before filing: verify whether the country of origin or any stringent regulatory authority has issued an alert or a recommendation of non-approval for the product (Article 87, item 5, and Article 38, second paragraph, item 1).
• Organise the evidence chain around the essential principles: map each of the five essential principles of Article 6 point by point onto the technical documentation so that Article 87, item 1 cannot be invoked.
• Route all foreign documents through proper translation and authentication chains and eliminate any form of alteration or substitution (Article 87, item 3).
• Confirm exclusivity arrangements before multi-channel registration: where exclusive distribution exists, submit the proof required by Article 40 to avoid falling into duplicate authorisation under Article 87, item 4.
• Scale clinical and performance evidence to the risk class: Classes IIB and III carry the additional requirements of Articles 45 and 46 respectively, avoiding rejection for insufficient evidence under Article 87, item 2.
• Retain all records of technical communication with ARSA as reference material for the technical-legal analysis stage of Article 87, item 8.

5. Verification checklist

• □ Global alert status self-check completed (country of origin and stringent regulatory authorities)
• □ Mapping table between the five essential principles of Article 6 and the technical documentation prepared
• □ Translation and authentication chains for foreign documents complete, with no signs of alteration
• □ Exclusive distribution arrangements confirmed and duplicate-authorisation risk ruled out
• □ Performance and clinical evidence scaled to the risk class and archived
• □ Records of technical communication with ARSA archived for reference

Related reading: [Article 44 — Five cancellation grounds and eight sale prohibitions](/honduras-medical-device-registration/cancellation-grounds-article-88/) | [Article 42 — Reclassification and referral to DNPF](/honduras-medical-device-registration/reclassification-and-referral-to-dnpf/) | [Article 24 — Additional requirements for Class III](/honduras-medical-device-registration/class-iii-additional-requirements/)

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