MSPAS · Americas

Guatemala medical device regulatory resources

Every Guatemala dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with records3 regulations trackedSep 2026 fees reviewed

Run the classification agent

Everything we track for Guatemala

AI medical device classifier

Describe your device and get a preliminary MSPAS risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Guatemala requirements.

Government registration fees

Review current MSPAS application, review, and renewal fees.

Registration timeline

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.

Structured regulatory requirements

Explore all 36 source-linked facts →

24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

MSPAS, through the DRCPFA, is the competent authority for related products: The competent authority for the sanitary control of medicines and related products, which by law include medical devices and diagnostic reagents, is the Ministerio de Salud Pública y Asiste…

1 source-linked fact

Checked 2026-09-16

Open details →

D02

Legal basis & guidance

Verified

NT-37 was issued under AG 712-99 Art. 4 and the MSPAS organic regulation: The DRCPFA's power to issue the device technical norms derives from AG 712 99 Art. 4, from Art. 35 of the MSPAS Organic Regulation (Acuerdo Gubernativo 115 99) and from the Código de Salud.…
The 'registro sanitario de referencia' instrument does not cover devices: AG 712 99 Art. 10 confines the 'registro sanitario de referencia' to pharmaceutical specialities, biological products, radiopharmaceuticals, homeopathic products and pesticides. Medical dev…

3 source-linked facts

Checked 2026-09-16

Open details →

D03

Device definition & scope

Verified

Device definition and the boundary with medicines: NT 37 defines a medical device as any instrument, apparatus or other similar or related article, used alone or in combination, including its components, parts and accessories that take part…
IVD reagent definition and three risk categories: NT 40 defines an in vitro diagnostic reagent as a reactive product or calibrator, used alone or in association with others, intended for the study of samples from the human body, including…

2 source-linked facts

Checked 2026-09-16

Open details →

D04

Classification rules

Verified

Clases I, II, III y IV — NT-37 versión 5-2016, Anexo 1: Clase I — inscripción sin análisis (no estéril de uso externo), Clase II — inscripción con análisis (estéril de uso externo), Clase III — inscripción con análisis (no estéril de uso interno), Clase IV — inscripción con análisis (estéril de uso interno)

1 maintained scheme

Checked 2026-09-16

Open details →

D05

Registration pathways

Verified

IVDs take the same inscription route under their own norm, NT-40 v3-2015: In vitro diagnostic reagents take a separate but structurally identical route: the Inscripción Sanitaria under Norma Técnica Número 40 versión 3 2015, again a single inscription with no abr…
One pre-market route for devices: Inscripción Sanitaria under NT-37 v5-2016: Medical devices reach the Guatemalan market through a single pre market route: the Inscripción Sanitaria governed by Norma Técnica 37 versión 5 2016, which yields a Certificado de Inscripci…

2 source-linked facts

Checked 2026-09-16

Open details →

D06

Reliance & recognition

Verified

A US FDA, DGKC or IFCC credential can satisfy the manufacturing-guarantee dossier item: statement: For the addition of an alternative manufacturing plant, NT 37 requires a manufacturing guarantee certificate issued by a health authority and names as acceptable sources Good Man…
Homologation on a WHO-listed-authority approval exists but is scoped to medicines and vaccines, not devices: statement: Guatemala does operate a reliance route: Norma Técnica 77 versión 8 2023 homologates a Guatemalan health registration on a registration already granted by a WHO listed authority…

5 source-linked facts

Checked 2026-09-16

Open details →

D07

Economic-operator roles

Verified

Only establishments licensed as importers may import devices: A device may be imported only when it is registered or inscribed before the DRCPFA, and only establishments holding a current sanitary licence as importer may carry out the importation. Unl…
Application must be signed by a local Químico Farmacéutico and accompanied by the manufacturer's power of representation: The device inscription application must be signed, sealed and stamped by a professional Químico Farmacéutico, and the dossier must include an authenticated copy of the manufacturer's power…

3 source-linked facts

Checked 2026-09-16

Open details →

D08

Establishment, import & distribution

Verified

Twenty licensed establishment classes include device factories, IVD factories, droguerías and distributors: AG 712 99 Art. 71 enumerates twenty classes of establishment subject to sanitary licensing, among them 'Fábrica de material de curación y otros' (71.8), 'Fábrica de reactivos para diagnósti…

1 source-linked fact

Checked 2026-09-16

Open details →

D09

Dossier requirements

Verified

Closed 13-item dossier for device inscription: The device inscription dossier is a closed list of thirteen items: proof of fee payment for the inscription procedure, which also covers sanitary surveillance; the F AS f 08 application sig…

1 source-linked fact

Checked 2026-09-16

Open details →

D10

Official forms & portals

Verified

Current inscription and update forms (F-AS-f-08 V 24-2025, F-AS-f-10 V 13-2025): statement: Related product inscription is applied for on MSPAS form F AS f 08, 'Solicitud de Inscripción Sanitaria de Productos Afines', whose current version is V 24 2025 and which enters…

1 source-linked fact

Checked 2026-09-16

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

Instructions for use and warnings must appear in Spanish on imported devices: Secondary packaging of a medical device must carry the mode of use or instructions for use and the warnings; for imported products that information must appear in Spanish. The same rule app…

1 source-linked fact

Checked 2026-09-16

Open details →

D12

QMS, audit & inspection

Verified

All device and IVD establishments are licensed and inspected by the DRCPFA: Every establishment in the device and IVD supply chain — manufacturing plants, droguerías and distributors among the twenty classes listed in AG 712 99 Art. 71 — must hold a sanitary licenc…

1 source-linked fact

Checked 2026-09-16

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

Medical electrical safety and EMC evidence inside the sanitary inscription: Electrical safety
MEM radiation-practice operating licence and radiological protection officer licence: Radiation

2 maintained overlays

Open details →

D14

Fees

Verified

Inscripción Sanitaria de Producto Afín (medical devices) — arancel item IA1: GTQ 100
Renovación de Inscripción Sanitaria de Producto Afín — arancel item IA2: GTQ 100

8 maintained fee lines · 1 related fact

Checked 2026-09-16

Open details →

D15

Review clocks

Verified

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: 20 working days
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: 20 working days
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: 15 working days

5 maintained pathways · 1 related fact

Checked 2026-09-16

Open details →

D16

Approval validity & renewal

Verified

Five-year validity; late renewal means cancellation and a fresh inscription: A device inscription is valid for five years from the date of grant. Renewal must be applied for before expiry. If the renewal documentation is not filed before the expiry date of the initi…

1 source-linked fact

Checked 2026-09-16

Open details →

Lifecycle & post-market

D17

Change control

Verified

Two categories of change: notification and DRCPFA authorisation, filed on F-AS-f-10: Changes to a device inscription fall into two categories — those requiring notification and those requiring authorisation from the DRCPFA — and are filed on form F AS f 10, 'Solicitud de Ac…

1 source-linked fact

Checked 2026-09-16

Open details →

D18

UDI, listing & traceability

Verified

Customs release conditioned on DRCPFA-authorised import documents carrying the registration number: For the products within AG 712 99's scope — which include material de curación, medical surgical material, dental products and equipment, and laboratory diagnostic reagents — import is perm…

1 source-linked fact

Checked 2026-09-16

Open details →

D19

Clinical investigation & performance

Verified

Device clinical-investigation authorisation: the device-specific dossier under AM 206-2021: A clinical investigation of a medical device in Guatemala requires the research protocol to be authorised by the DRCPFA under Acuerdo Ministerial 206 2021. For a device trial the sponsor, i…

1 source-linked fact

Checked 2026-09-16

Open details →

D20

Special access & derogation

Verified

Compassionate use: definition covering medical devices and the Department's authorisation route: Acuerdo Ministerial 206 2021 defines 'uso compasivo' as the use of a medicine or medical device in isolated patients, outside a clinical trial, including pharmaceutical specialities for ind…

1 source-linked fact

Checked 2026-09-16

Open details →

D21

Manufacturer PMS

Verified

The national pharmacovigilance norm NT 19-2009 places its post-market obligations (Arts. 9–12: ADR register, 15-day serious-case reporting, periodic safety reports, responsible professional) on companies authorised to market medicines; device marketers are not named: Chapter III of Normativa 19 2009 imposes obligations on 'la empresa autorizada para la comercialización de medicamentos': keep a detailed register of suspected adverse reactions, report ser…
Device adverse events and quality failures are notified to the National Pharmacovigilance Programme on form F-FV-c-04 (v03-2025) by e-mail to farmacovigilanciadrcpfa@mspas.gob.gt or at the DRVCS window: The Boleta de Notificación de Tecnovigilancia F FV c 04 version 03 2025 is the official form for reporting adverse events or quality failures of medical devices. It is sent to farmacovigila…

3 source-linked facts

Checked 2026-09-16

Open details →

D22

Vigilance & incident reporting

Verified

Adverse device incidents must be notified by all health personnel: Adverse incidents involving medical devices must be notified to MSPAS under the procedure established by Acuerdo Ministerial 418 2014, which covers suspicion of quality non compliance, ther…

1 source-linked fact

Checked 2026-09-16

Open details →

D23

Recall, FSCA & market surveillance

Verified

Public register of complaints, deviations and market withdrawals covering devices and IVDs: The DRCPFA maintains and publishes a register of notifications of complaints or claims, deviations (thefts) and withdrawals of product from the market, covering 'productos farmacéuticos, af…

1 source-linked fact

Checked 2026-09-16

Open details →

D24

Advertising, claims & promotion

Verified

Advertising of health-products-chapter products must be truthful, exact, balanced and current: The Código de Salud requires that all advertising, promotion or propaganda for the products covered by its health products chapter be governed by ethical criteria and give the user truthful…

1 source-linked fact

Checked 2026-09-16

Open details →

D25

Submission communications & appeal

Verified

Positive administrative silence for certifications, authorisations and opinions: All petitions that involve the issuance of a certification, an authorisation or an opinion are deemed resolved favourably where the competent authority, under the Código de Salud and its re…
Deficiency note, remedy of non-conformities and closure of the application: In the DRCPFA's procedure for entry and evaluation of related product inscription files (F AA p 01), the applicant submits the application to the DRCPFA and the National Health Laboratory (…

2 source-linked facts

Checked 2026-09-16

Open details →

Government fees

Full fee schedule (8 lines) →

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

4 more fee lines on the full schedule · 8 of 8 rows source-verified

Registration timeline

Full registration timeline →

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)	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)	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)	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)	20 working days	1-2 months	Verified

1 more pathways on the full timeline · 5 of 5 clocks source-linked

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(20 working days)
5Registration Approval(1-2 weeks)

Key regulations

All 3 Guatemala regulations →

Official MSPAS rules and guidance · 3 of 3 documents linked to official sources

Acuerdo Gubernativo 712-99Reglamento para el Control Sanitario de los Medicamentos y Productos Afines

GeneralVerified

Acuerdo 506-2002 / Resolución 93-2002 (COMIECO-XXIV)Acuerdo No. 506-2002 que publica la Resolución No. 93-2002 (COMIECO-XXIV) — Reconocimiento de Registros Sanitarios de Medicamentos y Formato Único de Certificado de Producto Farmacéutico

RegistrationVerified

Cuadro Resumen — Pago de Aranceles (DRCPFA y LNS)Cuadro Resumen — Pago de Aranceles en el Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA) y Laboratorio Nacional de Salud (LNS)

GeneralVerified

Continue with this market