Honduras medical device regulations

Complete one-page official communiqué dated and published 27 April 2026. Announces revocation of Agreement 0142-ARSA-2025 through Agreement 0114-ARSA-2026 from that date. The PDF is publicly linked by ARSA’s own arsateca site; its original image accompanies Spanish OCR. The legal agreement was subsequently published in the Gazette on 18 June 2026.

Complete one-page original dated 8 April 2026. Requires TGR-1 payment for device-directorate services from 16 April 2026, using revenue item 12209 and institution 62. Gives the official calculator/payment sequence, requires one correctly valued receipt per procedure, and separately identifies other directorates’ payment items. The quoted Fiscal Year 2025 budget reference is preserved as printed; it is not silently changed to 2026.

Complete two-page official notice dated 24 February 2026. Announces availability from 25 February 2026 of online SOL procedures for exhaustion of labels/packaging/IFU, device notifications and product/service classification certificates, implementing C-ARSA-015-V1 and C-ARSA-019-V1. Original page images retain the printed procedure identifiers and QR code alongside Spanish OCR.

Complete original agreement signed 20 September 2021, published 4 October 2021 in La Gaceta 35737. Includes risk classification, device registration, modifications and research fees; point 3 is still expressly referenced for online registration modifications by C-ARSA-019-V1 in February 2026. Its closing clause displaces only the named online-service portions of Agreement 012-2020 and specified earlier clinical-trial fees. Read with later clinical Agreement 0256-ARSA-2025; this is the original 2021 expression, not a current consolidation. The first right column and last left column exclude neighbouring electricity/mining instruments. Mixed column/table layouts are segmented in reading order, with original table pages retained.

Complete seven-page original law with 15 articles, published 12 June 2021 in La Gaceta 35626 and effective on publication. Establishes ARSA’s legal authority over medical devices and other regulated products, authorisations, inspections, fees, sanctions and remedies. Both Gazette columns are preserved in reading order.

Complete 26-page original, signed 19 February 2021 and published 23 March 2021 in La Gaceta 35552. Covers establishment and transport licences, special authorisations, inspection, surveillance and destruction services, expressly including the device directorate. Resolutive point 12 displaces only the named provisions of Agreements 091-2018, 082-2019 and 012-2020 and contrary provisions. Salary fractions and fixed amounts retain their original service/modality columns. Pages 5–26 require fresh Spanish OCR because the PDF overlays invisible, unrelated text on the visible tables; mixed column/table pages are segmented before OCR, and all original table pages accompany the transcription. Read with later applicable device notices and fee/payment rules; this is not a consolidated tariff.

Official ARSA regulation covering medical-device establishment licences, risk classification, registration, post-registration changes, importation, labelling, vigilance, inspections and sanctions. The regulator-hosted 93-page publication is retained in the original Spanish.

Complete original agreement signed 27 April 2026 and published 18 June 2026 in La Gaceta 37171. Expressly revokes Agreement 0142-ARSA-2025 in its entirety and remits the subject for technical/legal revision. The agency also announced the revocation from 27 April in communiqué C-ARSA-025-V1; both the signature/announced execution date and later Gazette publication are preserved. Do not treat the revoked 2025 advertising requirements as current.

Complete original agreement published in La Gaceta 37055 on 28 January 2026, signed 5 December 2025. Expressly includes medical-device clinical trials, research-site licences, modifications, requirements, fees and decision periods. The closing clauses revoke Agreement 041-2020 and its amendments and amend the specified portions of Agreement 031-2021. Commences thirty days after Gazette publication. The extraction follows each Gazette column in order, taking only the right column of the first physical page and the left column of the last; neighbouring advertising and maize-flour instruments are excluded.

Complete ten-page original, signed 25 June 2020 and published 30 June 2020 in La Gaceta 35299. Contains fixed amounts and salary-based fractions by risk class, service, resolution period and online/in-person modality. Item 4 remains expressly referenced for in-person modifications with prior approval in February 2026 communiqué C-ARSA-019-V1. Other portions have separate later amendments, including Agreements 003-2021 and 31-2021; do not read this original as a consolidated current tariff. Mixed Gazette columns and tables are retained in reading order, with table images.

Complete four-page official communiqué dated 20 February 2026. Provides separate online/in-person fee fractions and business-day periods for notifications, exhaustion, classification, establishment activities and specified modifications. Its closing note refers registration modifications to Agreement 12-2020, item 4 (in person), and Agreement 31-2021, item 3 (online); the tables state fee fractions, with the applicable calculation base governed by the referenced fee agreements. Read with C-ARSA-015-V1. Original fee-table pages accompany layout text.

Official ARSA application DDM-F-006, version 01, for modification of a medical-device registration. Includes the dossier number, applicant and representative details, product and establishment information, existing registration number and validity, and signature. The general application form does not provide a complete list of evidence for every type of modification, and its unselected processing-time choices do not establish a universal decision period.

Complete official six-page PDF form DDM-F-003 version 01. Retains the original fields, declarations and checkboxes as searchable text, with the unmodified official source linked. No publication or commencement date is inferred from the upload path. Read alongside current device and technovigilance rules and applicable later communications.

Complete historical six-page original, dated 24 July 2020. Expressly replaced by C-ARSA-015-V1 on 6 January 2026. Kept for the legal change history and direct stable citations; excluded from current broad discovery/search. A fresh Spanish OCR replaces the damaged original text layer.

Complete 19-page original communiqué dated 6 January 2026. Replaces C-010-ARSA-2020 expressly and displaces conflicting earlier communications of equal or lower rank. Separately states product, establishment and transport modifications, notification requirements, label/packaging stock exhaustion and product/service classification certificates; subject to later applicable fees. Original table geometry is retained alongside searchable layout text.

Official ARSA application DDM-F-004, version 01, for a new medical-device registration. Includes applicant and representative details, holder, manufacturer, distributor and product information, and a signature. Its unselected choices of 5, 10, 20, 30 or 60 working days do not establish a universal decision period.

Official ARSA sworn declaration DDM-F-001, version 01, for a new medical-device registration. Records the holder, manufacturer, distributor and product details, together with declarations on conformity, safety alerts, responsibility and signatures.

Complete 14-page original dated 12 August 2025, including the exemption list, certificate requirements and transitional dispositions. Expressly sets aside C-008-ARSA-2020, requires an exemption certificate before the listed activities and gives transitional periods for pending/non-exempt products and old certificates. Commences the day after publication; the date printed on the notice is not assumed to be its publication date.

Official ARSA application DDM-F-005, version 01, for renewal of a medical-device registration. Includes the dossier number, applicant and representative details, product and establishment information, existing registration number and validity, and signature. Its unselected processing-time choices do not establish a universal decision period.

Official ARSA sworn declaration DDM-F-002, version 01, for renewal of a medical-device registration. Includes holder, manufacturer, distributor and product details, the existing registration number and validity, responsibility declarations and signatures.

Complete two-page official version 2, published 21 January 2026. Requires the number/image of the updated establishment RTN for new, renewed and modified sanitary licences. Extends free updates for existing licence holders only until 6 February 2026; later modifications incur the applicable fee. Medical-device establishments use SOL, while specified other product categories use a different form. The free-transition period has ended; it is not represented as a currently free modification. Original pages retain both QR codes and exact date alongside Spanish OCR.

Current original ARSA public service guidance, extracted from 35 reachable procedure panels in the page’s declarative selector configuration. Separate sections retain registration by risk class, renewal, 18 registration-change categories, establishment and transport licences, classification changes, import exemptions, labelling and insert design, packaging changes, and other notifications. Procedure labels preserve each panel’s applicability; one unreachable exact duplicate is excluded. This undated web guidance must be read with binding Agreement 0631-ARSA-2023, January 2026 modification/notification communiqué C-ARSA-015-V1, February 2026 fee communiqué C-ARSA-019-V1 and the subsequent clinical-trial agreement 0256-ARSA-2025. Some website requirements are abbreviated; the complete notices and binding originals govern. Retrieval and website modification dates are not treated as legal commencement dates.

Official DNDM-F-001 version 02 workbook for describing donated medical devices, including product purpose, model, serial, presentation, expiry, batch, brand and origin, with completion notes and examples. All original worksheet cells were reviewed. Searchable date-style examples are normalised by the existing workbook parser; an example date and the printed one-page claim do not establish legal dates or actual print pagination.

Dated 7 May 2020, this ARSA communication updates No. 013-ARSA-2017 and sets requirements for pre-import risk classification reports, their extension and modification. It specifies six-month validity, one extension requested at least ten days before expiry, and modifications retaining the report’s nomenclature and validity. Recovery fees are required without a stated amount. Article 31 of the later binding Regulation under Acuerdo 0631-ARSA-2023 retains an initial six months and one six-month extension, but expressly permits an extension request at any time before expiry. This conflicts with the earlier ten-day instruction; it does not establish express repeal of the whole communication. Other requirements and later currentness remain unverified.

ARSA guidance presents 28 risk classification rules for human medical devices, including IVDs, using Classes I, IIA, IIB and III. It covers definitions, non-invasive and invasive devices, active devices, special rules, examples and graphical summaries, and cites Title V of Acuerdo 0631-ARSA-2023. The source prints publication year 2025 without a full legal effective date. Conflicting class labels and rule wording are preserved for review; the guide does not establish a universal rule for all laboratory products.