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Guatemala medical device registration timeline

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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 end-to-end planning ranges, using the 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 system.

5 pathways5 of 5 clocks verifiedvalidity 5 years from the date of grant, renewable (NT-37 Arts. 8-9; NT-40 Art. 4.3)MDSAP not acceptedreviewed 2026-09-16tramites.gob.gt
Class / pathwayReview clockPlanning totalWith prior approvalProvenance
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.
20 working days1-2 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analysis, and the norm provides that a product which fails analysis has its inscription automatically cancelled and is withdrawn within no more than 15 days.
20 working days1-3 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.
15 working days1-2 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.
20 working days1-2 months—Verified
IVD reagent — renewal (Categorías I, II and III)(Renewal under NT-40, filed with the DRCPFA)
RENOVACIONES: 15 días hábiles on trámite 3357; trámite 3358 publishes the same 15 working days for a renewal where the formula did not change.
15 working days1-2 months—Verified
Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Guatemala Medical Device Registration Process

Step-by-step MSPAS registration process. Total estimated timeline: 1-2 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MSPAS. Appoint a Titular / representante legal — a Guatemalan establishment holding a sanitary licence issued under Acuerdo Gubernativo 712-99, appointed by an authenticated power of representation from the manufacturer (NT-37 Art. 5.1.7).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MSPAS including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MSPAS reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

20 working days

In-depth technical assessment of device safety and performance. MSPAS may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MSPAS issues Guatemala market authorization certificate.

Summary: The Guatemala medical device registration process through 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) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)A foreign marketing approval is not among the NT-37 Art. 5.1 dossier items and opens no recognition route for devices. A Certificate of Free Sale from any competent origin-country authority is required paperwork, and a manufacturing-guarantee certificate from a named authority (FDA, DGKC, IFCC, ISO or a GMP certificate) satisfies one dossier item (NT-37 Arts. 5.1.5-5.1.6 and 6.12.6). The full local review still runs.
PAHO/PARF regional reference authorities (ARNr) and COMIECO member statesNo device relevance was found. Guatemala's COMIECO mutual recognition of health registrations is confined by the annex to its own resolution to pharmaceutical products originating in the customs-union member states (Acuerdo Ministerial 506-2002, Annex 1 of Resolución 93-2002), and the published RTCA instruments on the MSPAS index cover medicines, natural medicinal products, cosmetics, hygiene products and pesticides, not devices or IVDs.
Key requirements
  • The application must be signed, sealed and stamped by a professional Químico Farmacéutico (NT-37 Art. 5.1.2).
  • The registering establishment must hold a current sanitary licence issued under Acuerdo Gubernativo 712-99, and only establishments holding one may import (NT-37 Art. 5.1.13; AG 712-99 Arts. 52 and 72).
  • The dossier must include a Certificate of Free Sale from the competent health authority of the origin country and a GMP or manufacturing-guarantee certificate for the manufacturing laboratory (NT-37 Arts. 5.1.5-5.1.6).
  • Foreign documents must satisfy Guatemalan legal requirements to be valid, and documents in a language other than Spanish must be translated by a sworn translator authorised in Guatemala (NT-37 Arts. 5.2.4-5.2.5).
  • The file is submitted in a natural-coloured folder with a clip for devices and a black folder for IVD reagents.
  • Secondary-packaging use instructions and warnings must appear in Spanish for imported products (NT-37 Art. 7.1.2).
  • The inscription runs five years from grant and renewal must be filed before expiry (NT-37 Arts. 8-9; NT-40 Art. 4.3).
  • There is no abridged or recognition route for devices or IVDs: the NT-77 v8-2023 homologation on a WHO-listed authority registration is confined by its Art. 2 to chemical-synthesis medicines and vaccines, and trámite 3502 mutual recognition to medicines for human use.
Primary regulator sources
tramites.gob.gt · Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record) tramites.gob.gt · Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuesta medicamentos.mspas.gob.gt · Norma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Arts. 5, 8, 9 y Anexo 1 medicamentos.mspas.gob.gt · Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Arts. 3 y 4.3 medicamentos.mspas.gob.gt · Norma Técnica 77 versión 8-2023 — homologation on a WHO-listed authority registration, Art. 2 (scope: chemical-synthesis medicines and vaccines only)

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against MSPAS publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:guatemala:device-class-i-inscription