MSPAS market accessResearch MSPAS registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Guatemala medical device resource.
Describe your device and get a preliminary MSPAS risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Guatemala requirements.
Review current MSPAS application, review, and renewal fees.
Compare official and realistic approval times by device class and pathway.
Browse Guatemala's official medical-device instruments — the Reglamento para el Control Sanitario de los Medicamentos y Productos Afines, the COMIECO resolution, and the DRCPF tariff table — with citeable Spanish passages.
Common questions about changing a registered medical device in Guatemala. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-16
MSPAS registration fees in GTQ · reviewed 2026-09-16
| Fee line | Amount | Provenance |
|---|---|---|
| Inscripción Sanitaria de Producto Afín (medical devices) — arancel item IA1 | GTQ 100 | Verified |
| Renovación de Inscripción Sanitaria de Producto Afín — arancel item IA2 | GTQ 100 | Verified |
| Certificado de Actualización de Expediente de Inscripción Sanitaria de Producto Afín — arancel item IA3 | GTQ 50 | Verified |
| Inscripción Sanitaria de Reactivos para Diagnóstico in vitro (IVD) — arancel item IA1 | GTQ 100 | Verified |
Ministerio de Salud Pública y Asistencia Social — Dirección General de Regulación, Vigilancia y Control de la Salud, Departamento de Regulación y Control de Productos Farmacéuticos y Afines (MSPAS) review clocks and planning ranges · 4-class for devices (Clase I, II, III, IV — NT-37 v5-2016 Anexo 1) and 3-category for IVDs (Categoría I, II, III — NT-40 v3-2015 Art. 3) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Clase I — inscription without analysis (non-sterile, external use)(Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA in a natural-coloured folder) NUEVOS: 20 días hábiles is the MSPAS published response time on the national trámites record. NT-37 v5-2016 itself fixes no period, so this is a service standard rather than a statutory maximum. Anexo 1 places Clase I in inscription without analysis, and trámite 3361 step 2 records that the Laboratorio Nacional de Salud analysis is not currently required for any device file, so Clase I and the higher classes run the same clock today. | 20 working days | 1-2 months | Verified |
| Clases II, III and IV — inscription with analysis(Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA) Anexo 1 assigns Clases II, III and IV to inscription with physicochemical and microbiological analysis, and the norm provides that a product which fails analysis has its inscription automatically cancelled and is withdrawn within no more than 15 days. The published 20-working-day clock covers the file as it runs today, with the analysis step recorded as not currently required; if analysis were reinstated the clock would not necessarily move, because the trámite record publishes one figure for the whole procedure. | 20 working days | 1-3 months | Verified |
| Renovación de la Inscripción Sanitaria (all classes)(Renewal under NT-37 Arts. 8-9, filed on form F-AS-f-08 before expiry; where nothing changed, proof of payment plus a notarised declaration and a copy of the previous certificate) RENOVACIONES: 15 días hábiles on trámite 3361; the same figure is published for the no-formula-change variant on trámite 3362. The inscription is valid for five years from grant and renewal must be filed before expiry (NT-37 Arts. 8-9); if the renewal file is not filed in time the inscription lapses. | 15 working days | 1-2 months | Verified |
| IVD reagent — new inscription (Categorías I, II and III)(Inscripción Sanitaria under NT-40 v3-2015, filed with the DRCPFA in a black folder) NUEVOS: 20 días hábiles on trámite 3357, whose normativa is NT-40 v3-2015. The IVD track is a separate trámite from the device track but publishes the same clocks. NT-40 Art. 4.3 fixes the validity at five years from grant; NT-40 itself contains no review period. | 20 working days | 1-2 months | Verified |
Official MSPAS rules and guidance · 3 of 3 documents linked to official sources
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Connect the MSPAS route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against MSPAS administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to MSPAS evidence, notification, timing, and implementation questions.
Assess a current MSPAS update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Guatemala (MSPAS).
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