Who Regulates Medical Devices in Honduras

1. Key takeaways

The competent authority for medical devices in Honduras is the Agencia de Regulación Sanitaria (ARSA), with execution carried out by its Dirección de Dispositivos Médicos y otros Dispositivos de Interés Sanitario (Directorate of Medical Devices and Other Devices of Sanitary Interest). ARSA was created by Decreto Ejecutivo PCM-032-2017 (issued on 2017-04-28 and published on 2017-05-19) and its creation was ratified by the National Congress through Decreto No. 7-2021 (La Gaceta No. 35,626, 2021-06-12), Article 1. Article 7 of that law lists 10 principal powers: item 2 covers issuing and updating the normative framework, item 4 covers issuing, renewing, modifying, suspending and cancelling product sanitary registrations and other sanitary authorisations, and item 1 expressly covers technovigilance.

• ARSA is a legal person with functional, technical, financial and administrative independence, so the framing that the Ministry of Health is the authorising body for devices is outdated; dossiers prepared on that old basis are filed with the wrong door.
• All device authorisations issued after 2024-09-21 are issued in the name of ARSA.
• Registration and technovigilance sit under the same directorate, so one team can own both contact points.
• The Comisionado Presidente is the highest authority and legal representative of ARSA under Article 2 of Decreto No. 7-2021.

2. Legal basis

The table below maps each level of the framework to the provision relied upon.

3. Expert insights

Insight 1: the path of creation determines who you file with. ARSA was first created by presidential decree and later ratified by legislation of the National Congress, a path that gives it both a subordinate-to-ministry character and the character of an independent legal person. For applicants the test is a single one: the issuing body and seal on the authorisation document. Any device authorisation issued after 2024-09-21 must be issued by ARSA; a device authorisation issued in the name of a ministry cannot be used for import or sale.

Insight 2: Article 7 places rule-making and certificate-issuing in the same body. Item 2 empowers ARSA to issue and update the normative framework, and item 4 empowers it to issue, renew, modify, suspend and cancel product registrations. Honduras therefore has no separation in which one body writes the rules and another executes them. The direct consequence for applicants is that the counterpart for objections and reconsideration is also ARSA: remedies follow the procedures of ARSA itself, not a higher sectoral authority.

Insight 3: technovigilance and product registration hang from the same directorate. Article 78 attaches the Centro Nacional de Tecnovigilancia (CNTV) to the Directorate of Medical Devices and Other Devices of Sanitary Interest, and Article 79 empowers ARSA to issue a separate vigilance regulation through the CNTV. This design means the window for post-market obligations is the same directorate as the registration window. The GRZAN regulatory team therefore advises placing the vigilance contact and the registration contact in the same team, so that post-market notifications do not circulate between two departments.

Insight 4: Article 12 set a 3-month legislative deadline for ARSA. Article 12 of Decreto 7-2021 required ARSA to issue its regulatory provisions within 3 months of the entry into force of the law. This explains the dense run of ARSA regulations after 2021, and it explains why 0631-ARSA-2023 was issued in the form of an Acuerdo: the normative output of ARSA travels the administrative-resolution (Acuerdo) route and takes effect only upon publication in La Gaceta.

Insight 5: the signature chain of the legal representative is a hidden gate for dossiers. Article 2 of Decreto 7-2021 establishes the Comisionado Presidente as the highest authority and legal representative. The signatory of 0631-ARSA-2023 was the Comisionada Presidenta. For companies, this determines the counterparty name on foreign authorisation letters and the addressee wording of the local apoderado legal power of attorney, both of which must match the name of the authority verbatim.

4. Practical recommendations

• Verify the issuing body of every authorisation document: for device authorisations issued after 2024-09-21 the issuer must be ARSA, not a ministry.
• Write the remedy route into internal SOPs: for refusal or cancellation decisions, prepare reconsideration submissions under ARSA procedures and deadlines, and do not look for a higher authority.
• Set up a single liaison window: registration, modification and vigilance notifications followed by the same team, keeping one contact with the Medical Devices Directorate.
• Check the letterhead and seals of foreign documents verbatim against the full name Agencia de Regulación Sanitaria; abbreviations are not accepted as a substitute.
• Track the rhythm of ARSA regulatory output: norms are issued as Acuerdos and require publication in La Gaceta, and the publication date and entry-into-force date usually differ by 20 days.
• Fix a one-page authority-and-competence table at the front of each dossier, noting the provisions relied upon and the issuing authority, to ease internal review.

5. Verification checklist

• □ The issuing and receiving authority for this application has been confirmed as ARSA and its Directorate of Medical Devices and Other Devices of Sanitary Interest
• □ The authority name and seals on authorisation documents have been checked, with no other nomenclature such as Ministry of Health
• □ The provisions cited come from 0631-ARSA-2023 (La Gaceta No. 36,646, 2024-09-21) or a regulation currently in force
• □ Internal SOPs state the reconsideration route and deadlines for refusal or cancellation decisions
• □ Registration and vigilance share the same contact, with no gap in the notification chain
• □ The letterhead of foreign authorisation documents matches the full name of ARSA verbatim

Regulatory information verified as of 2026-10-29.

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com