MSPAS current fee schedule, reviewed for 2026, in GTQ.
8 fee lines100% exact amountscurrency GTQFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Inscripción Sanitaria de Producto Afín (medical devices) — arancel item IA1 Arancel item IA1 of boleta V-CC-G-001 v11-2022. The same Q 100 is published on the national trámites record 3361 for a new device inscription, in a natural-coloured folder. | GTQ 100 | $13.10 | Per inscription file (expediente) | Verified |
| Renovación de Inscripción Sanitaria de Producto Afín — arancel item IA2 Arancel item IA2. Trámite 3362 (renewal where no formula change occurred) publishes the same Q 100 with a 15-working-day clock. | GTQ 100 | $13.10 | Per renewal file (expediente) | Verified |
| Certificado de Actualización de Expediente de Inscripción Sanitaria de Producto Afín — arancel item IA3 Arancel item IA3. Trámite 3363 (Solicitud de Actualización de Productos Afines) publishes Q 50 against the same item. | GTQ 50 | $6.55 | Per product updated | Verified |
| Inscripción Sanitaria de Reactivos para Diagnóstico in vitro (IVD) — arancel item IA1 The arancel charges IA1 per expediente of 'productos afines', the statutory category that Art. 9 of Acuerdo Gubernativo 712-99 defines to include 'reactivos de laboratorio para uso humano'. The national trámites record 3357 nevertheless publishes 'Costo: Q 0' for a new IVD inscription while its own renewal variant (3358) publishes Q 100; the catalogue figure is treated as stale rather than as a verified zero, and Q 100 is the amount the tariff fixes. | GTQ 100 | $13.10 | Per inscription file (expediente) | Verified |
| Renovación de Inscripción Sanitaria de Reactivos para Diagnóstico in vitro — trámite 3358 Published on the trámite record as Q 100 with a 15-working-day response time; normativa NT-40 v3-2015. | GTQ 100 | $13.10 | Per renewal file (expediente) | Verified |
| Reconocimiento Mutuo de Producto Afín — arancel item RMA1 The arancel carries a mutual-recognition item for related products at Q 800, but no device or IVD mutual-recognition procedure is published in the national trámites catalogue: trámite 3502 (Registro Sanitario Nuevo Reconocimiento Mutuo, Q 750, 10 working days) is confined to medicines for human use under RTCA 11.03.59:18 Annex II and Resolución 446-2021, and trámite 3495 (homologation) is pharmaceutical-only. The item therefore has no device track today. | GTQ 800 | $105 | Per recognition file (expediente) | Verified |
| Autorizaciones Publicitarias — arancel item PU1 Advertising and promotion of related products — the statutory category that includes medical devices — requires DRCPFA authorisation under Normativa No. 53-2006, filed on form F-AS-f-14; the arancel prices item PU1 at Q 25. | GTQ 25 | $3.27 | Per authorisation | Verified |
| Licencia Sanitaria de Farmacias, Droguerías y Distribuidoras — arancel item L3 A device may only be imported by an establishment holding a current sanitary licence (AG 712-99 Art. 52), and every establishment class in AG 712-99 Art. 71 must hold one (Art. 72); the arancel prices the pharmacy, droguería and distributor class at Q 170 and the laboratory/factory of related products (L2) at Q 500. | GTQ 170 | $22.26 | Per establishment licence | Verified |
Government fees only — service and testing costs are separate- Guatemala's arancel charges one flat item per inscription file, not per class: IA1 is the same Q 100 for a Clase I device and a Clase IV device. The low- and high-risk bands therefore carry the same figure.
- Every fee is paid through the same boleta V-CC-G-001, which is the instrument the arancel is published in; the slip header cites Acuerdo Gubernativo 53-2022 and Código de Salud Arts. 219 and 239(1) and Acuerdo Gubernativo 712-99 Art. 63.
- The companion arancel summary of 15 December 2022 fixes the folder colour per product family: Reactivos de Diagnóstico black, Productos Médico Quirúrgicos natural, Productos Odontológicos orange, Reconocimiento Mutuo brown.
- The national trámites catalogue shows 'Costo: Q 0' for a new IVD inscription (3357), for cosmetics (3351) and for hygiene products (3353) while showing Q 100 for devices (3361); the arancel knows a single IA1 item for all related products, so the zeros are catalogue artefacts and Q 100 is the enforceable amount.
- A verified zero does exist in this schedule: the arancel fixes no separate charge for the technical evaluation of the file itself, which the inscription fee covers together with sanitary surveillance (NT-37 Art. 5.1.1).
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Exact amounts verified against the MSPAS fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:guatemala:device-inscription-ia1