Recognition of ARN Registrations Under the GBT

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, provides in Article 47 that ARSA may recognise (podrá reconocer) the sanitary registrations of devices issued by national regulatory authorities (ARN) of maturity level 3 or 4, with maturity assessed according to the Global Benchmarking Tool (GBT) used by the World Health Organization (OMS) to evaluate national regulatory systems. The provision explains that the purpose of this requirement is to harmonise international standards of quality, safety and efficacy. Section I of Article 3 defines the GBT as the worldwide tool of the OMS for evaluating national regulatory systems for medical products, and separately defines the strictly regulated authority (Autoridad Reguladora estricta), used for the emergency use authorisation pathways of Article 42 and Articles 72 and 73. The GRZAN regulatory team notes that the threshold of Article 47 — maturity level 3 or 4 — is clearly lower than the strictly regulated authority standard, making this the most worthwhile international reliance pathway in this market; but the provision uses may rather than shall, so whether recognition is granted remains a case-by-case judgment of ARSA.

• ARSA may recognise device registrations issued by ARNs of GBT maturity level 3 or 4.
• The stated purpose is to harmonise international standards of quality, safety and efficacy.
• The GBT is defined in Article 3 as the OMS tool for evaluating national regulatory systems.
• The strictly regulated authority definition serves the emergency use pathways of Articles 42, 72 and 73.
• Recognition is discretionary, not mandatory, and is decided case by case.

2. Legal basis

The provisions below frame the recognition pathway, the definitions it rests on, and the requirements it leaves untouched.

3. Expert insights

Insight one: maturity level 3 or 4 and the strictly regulated authority are two different thresholds. Article 47 uses GBT maturity levels 3 or 4, while the strictly regulated authority defined in Article 3 requires the highest maturity level (usually corresponding to level 4). The two serve different pathways in the text: the former applies to recognition of registrations, the latter to the acceptance of emergency use authorisations. Companies should cite the correct threshold in their arguments and not confuse the two.

Insight two: the wording is podrá reconocer — may recognise — not shall recognise. This makes Article 47 an enabling norm, not an obligatory one: ARSA retains case-by-case discretion. The practical consequence is that holding a registration from a maturity level 4 country cannot be advanced as a ground for exemption from review; it should instead be submitted as supporting evidence, alongside the full set of ordinary documents required under Article 43 and below.

Insight three: Article 47 provides no reduction of documents. The provision only says registrations may be recognised; it lists no documents that may be waived and sets no exception to validity periods. This differs from the equivalent documents mechanism of Article 46.5, which expressly names 5 types of documents that may substitute when the prescribed documents cannot be submitted (including the CE certificate). Article 47 is therefore better suited to accelerating review than to cutting paperwork.

Insight four: the classification report precondition has not been waived. Article 31 requires ARSA’s own classification report before any sanitary registration, and Article 47 makes no exception to this. This confirms the design of Article 29: the risk class is determined by ARSA itself on the basis of intended use, and is not waived because another country has already classified the device.

Insight five: Article 90 reserves room for the reliance pathway to expand. The provision states that the regulation will be revised, updated or supplemented as international regulatory practice for medical devices advances, on the condition that scientific evidence supports the change. Together with the 180-day implementing-legislation window granted to ARSA by Article 93, implementing rules for Article 47 may be expected; the operational details of this article should be reviewed quarterly.

4. Practical recommendations

• Where a registration from a GBT maturity level 3 or 4 country is already held, submit it with the dossier as supporting evidence.
• Cite the thresholds precisely in arguments: maturity level 3 or 4 for registration recognition, strictly regulated authority for emergency use authorisations.
• Do not reduce the dossier because of an existing foreign registration; prepare the full set of documents under Article 43 and below.
• Still obtain ARSA’s own classification report first under Article 31; do not expect it to be waived.
• Review quarterly whether ARSA has issued implementing rules or operational guidance for Article 47.
• Add a page on international reliance at the front of the dossier, listing the foreign registration, its issuing authority and the maturity basis.

5. Verification checklist

• □ The GBT maturity level of the foreign issuing authority has been confirmed
• □ The foreign registration has been submitted with the dossier as supporting evidence
• □ The thresholds are cited accurately (maturity level 3 or 4 / strictly regulated authority)
• □ The ordinary dossier documents have not been reduced on account of the foreign registration
• □ ARSA’s classification report has been obtained under Article 31
• □ A quarterly review mechanism is set for implementing rules on Article 47

Further reading: [Article 09 — The four risk classes](/honduras-medical-device-registration/four-risk-classes-i-iia-iib-iii/) | [Article 02 — The four layers of legal sources](/honduras-medical-device-registration/honduras-medical-device-legal-framework/) | [Article 24 — What to add for Clase III](/honduras-medical-device-registration/class-iii-additional-requirements/)

Regulatory information verified as of 29 October 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