Sponsors who ask me about Honduras usually ask the wrong first question. They ask how long ARSA takes. The better first question is which Honduran company will file, because under the current device regulation the registrant, the risk-classification report and the establishment license move together, and the registrant is the one who can keep importing.
I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Honduras file: how a medical device that is already FDA-cleared or CE-marked gets onto the Honduran market through the Agencia de Regulación Sanitaria (ARSA), what changed with the 2024 regulation, and where sponsors lose control of the certificate. It sits next to our LATAM market-access hub, the Honduras ARSA country page and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.
One-sentence answer
To sell a medical device in Honduras you need an ARSA Registro Sanitario under Acuerdo No. 0631-ARSA-2023 (the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario), filed by a Honduran registrant that holds an ARSA Licencia Sanitaria, after first obtaining an ARSA risk-classification report; the registration lasts five years.
The rule that governs the file
ARSA was created under Decreto 7-2021, the Ley de la Agencia de Regulación Sanitaria. Its device regulation, Acuerdo No. 0631-ARSA-2023, is dated 28 December 2023 but was published in the official gazette La Gaceta (No. 36,646) on 21 September 2024, and by its own terms entered into force twenty days after publication. If an older SOP or distributor contract cites a different effective date, fix it before you file.
Article 5 lists the control tools ARSA uses for devices: Licencia Sanitaria for establishments, Clasificación por Riesgo, Registro Sanitario, exoneration from registration, special import authorizations, special donation authorizations and other product-specific permits. For a commercial launch you will touch at least three of them.
Three steps in a fixed order
1. The establishment license. The Honduran company that will import, store or distribute needs a current ARSA Licencia Sanitaria. Under Article 12 that license is issued for two, four or six years. No license, no filing.
2. The risk-classification report. Articles 31 and 33 make the informe de Clasificación por Riesgo Sanitario a precondition of registration. The report is valid for six months and can be extended once for another six months. You file the Registro Sanitario from the date the report or its extension is issued. Sponsors who let the classification lapse while translations drag on start this step again.
3. The Registro Sanitario. Article 33 requires a current sanitary authorization before import, storage, distribution, sale, rental, loan or advertising. Article 34 bars all of those activities without it.
Risk classes and what each adds
Article 29 classifies devices by intended use, anatomical site, contact duration, invasiveness and whether they deliver medicines or energy:
- Class I — low risk, general controls.
- Class IIA — moderate risk.
- Class IIB — high risk.
- Class III — very high risk, including devices that support or sustain life.
The Class I dossier in Article 43 is the base every higher class builds on. It includes the application, a sworn declaration in ARSA’s format, a certificate of free sale, the manufacturer’s GMP certificate, quality-control specifications, a safety report that lists existing sanitary alerts, a risk-management report, the registrant’s incorporation documents, primary and secondary labels plus a complementary Honduran label, and the power granted to the lawyer when a legal representative files. Class IIA adds ISO 13485 or equivalent regulator evidence (Article 44). Class IIB adds the device-specific ISO standards, for example ISO 10993-1 or ISO 14155 (Article 45). Class III adds certified biocompatibility, stability, cytotoxicity and electrical-safety testing, plus a finished-product certificate of analysis (Article 46). Medical software has its own list, including a cybersecurity report and version history.
The part sponsors miss: Article 40
Article 40 permits two or more sanitary registrations for the same device from different registrant companies, as long as there is no exclusivity between the product’s titular and a Honduran distributor. If exclusivity exists, the titular has to present the document that authorizes that distributor. Article 41 stops one company from filing two registrations for an identical device.
In practice, that makes Honduras a channel-design decision, not a paperwork exercise. If you sign an exclusive distribution agreement and let the distributor fund and file, you have handed the channel to that distributor for five years. If you keep the agreement non-exclusive and control who files, a second registrant stays possible. Read the distribution agreement and the power of attorney before you read the ARSA checklist.
Article 39 also helps on cost: devices from the same titular and manufacturer with the same risk class, intended use, indication and generic name, or sold together as a system or kit, can sit under one Registro Sanitario.
Validity, renewal and the dead zone
Under Article 35 the Registro Sanitario lasts five years. Renewal has to be requested at least five months before expiry. A late renewal is possible up to three months after expiry, with the service fee plus a fine. After that window you start a new registration. Once a registration expires, the registrant cannot import or sell the device. Put the renewal date on the same calendar as your distributor review, not in a regulatory folder nobody opens.
What this file is not
- It is not a clinical-trial authorization. Article 42 lets ARSA issue a special authorization to import devices without a Registro Sanitario in limited cases, including devices used in clinical trials whose protocols were approved by an ARSA-authorized scientific ethics committee. That import route covers study units only. It is not a license to sell. See our Honduras clinical trials page.
- It is not an ARSA timeline promise. I do not publish a statutory day-count for Honduras registro; confirm the current review window with ARSA when you plan the launch.
- It is not part of the bioaccess® fixed-price market-access subscription. That subscription runs in multi-importer model countries plus Argentina. Honduras is quoted case by case.
How bioaccess® runs Honduras registrations
On the live offer, bioaccess® processes Honduras registrations funded by the manufacturer: risk classification, dossier assembly, certified Spanish translation of labels, IFU and technical file, agency liaison through approval, and tecnovigilancia support. Your Honduran registrant holds the Licencia Sanitaria and the responsible technical professional; your distribution agreement, reviewed by local counsel, keeps transfer-on-demand and non-exclusivity terms on your side. ARSA fees are set by the regulator and scoped pricing is confirmed at proposal. See bioaccessla.com/market-access/honduras-arsa.
Operator checklist before you open a Honduras folder
- Pick the registrant first. Confirm it holds a current ARSA Licencia Sanitaria and a named responsible professional.
- Decide exclusive or non-exclusive before anyone files, and write the Article 40 consequence into the agreement.
- File the risk-classification report only when the dossier is close; you have six months plus one six-month extension.
- Map the FDA or CE evidence to the class-specific articles (43 to 46) instead of sending the US file as a zip.
- Group the family under Article 39 where the criteria fit.
- Calendar renewal at least five months before the five-year expiry.
- Run RF or telecom homologation for wireless devices as a separate track.
Talk with bioaccess® when you want Honduras registered without giving the channel away to the first distributor that offers to pay for the filing.