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MSPAS · structured requirements

🇬🇹 Guatemala medical device regulatory data

Explore the medical device requirements currently available for Guatemala, organized by topic and linked to official sources.

36 facts23 dimensions17 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising of health-products-chapter products must be truthful, exact, balanced and current

advertising.information-and-ethical-criteria
Fact-level verified

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, exact, balanced and up-to-date information, so that the user can apply their own judgement and take the option most in keeping with their interests.

Conditions
  • Art. 166 binds 'los productos que se contemplan en este capítulo'. That chapter's definitions article (Art. 164(k), added by Decreto 28-2011) defines 'Dispositivos médicos y material médico quirúrgico', while the Art. 163 enumeration lists medicines, cosmetics and other related categories without a separate device letter — so the device footing here is the chapter's own definition article, not an express device entry in the enumeration.

Spanish source (Guatemala). Verbatim: "Toda publicidad, promoción o propaganda que se haga sobre productos que se contemplan en este capítulo, debe regirse por criterios éticos, debe dar al usuario información fidedigna, exacta, equilibrada y actualizada, para que pueda aplicar su criterio y tomar la opción más acorde a sus intereses." Translation: "All advertising, promotion or propaganda for the products covered by this chapter must be governed by ethical criteria and must give the user truthful, exact, balanced and up-to-date information, so that the user can apply their own judgement and take the option most in keeping with their interests."

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Five-year validity; late renewal means cancellation and a fresh inscription

validity.five-year-term-and-renewal-before-expiry
Fact-level verified

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 initial authorisation, the DRCPFA treats the inscription as cancelled, and the applicant must file a new inscription meeting the full Art. 5 requirements. IVD inscriptions carry the same five-year term.

Conditions
  • Renewal where no modifications have occurred requires only proof of fee payment, the F-AS-f-08 application, a notarised sworn declaration that the original conditions still hold, and a simple copy of the previous inscription certificate (NT-37 Art. 9).
  • If the device has undergone unauthorised modifications, renewal must instead meet the full Art. 5 requirements.

Spanish source (Guatemala). Translation: "The validity of the registration or health inscription of medical devices shall be five (5) years counted from its grant. [...] The renewal of the health inscription of medical devices must be carried out in advance of its expiry." AG 712-99 Art. 49 states the cancellation consequence for inscriptions generally: 'La inscripción sanitaria puede ser renovada cada cinco años a petición del titular si no existen razones sanitarias en contra [...] Si no se presentara la documentación para renovación de la inscripción sanitaria antes de la fecha de vencimiento de la autorización inicial, EL DEPARTAMENTO la dará por cancelada.' NT-40 Art. 4.3 gives IVDs the same five-year vigencia.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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MSPAS, through the DRCPFA, is the competent authority for related products

authority.mspas-drcpfa-competent-authority
Fact-level verified

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 Asistencia Social (MSPAS), acting through the Dirección General de Regulación, Vigilancia y Control de la Salud and, within it, the Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA).

Conditions
  • AG 712-99 refers to the DRCPFA throughout as 'EL DEPARTAMENTO'.

Spanish source (Guatemala). Translation: "The Department of Regulation and Control of Pharmaceutical and Related Products of the General Directorate of Health Regulation, Surveillance and Control of the Ministry of Health, hereinafter called THE DEPARTMENT, shall issue the norms and forms necessary to put into practice the different processes and procedures set out in this Regulation." NT-37's own header block names the same chain: 'MINISTERIO DE SALUD PÚBLICA Y ASISTENCIA SOCIAL / DIRECCIÓN GENERAL DE REGULACIÓN, VIGILANCIA Y CONTROL DE LA SALUD, A TRAVES DEL DEPARTAMENTO DE REGULACIÓN Y CONTROL DE PRODUCTOS FARMACEUTICOS Y AFINES'.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Two categories of change: notification and DRCPFA authorisation, filed on F-AS-f-10

change-control.notification-versus-authorisation
Fact-level verified

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 Actualización de Inscripción Sanitaria de Productos Afines'. NT-37 Art. 6 enumerates the change types, including change of holder (6.1), change of the manufacturer's or holder's corporate name (6.2) and addition of an alternative manufacturing plant (6.12). All documentation must be in Spanish, with official translations for foreign documents.

Conditions
  • Adding an alternative manufacturing plant for the same manufacturer at a different site, keeping the same presentation and labelling, keeps the same inscription number but requires the manufacturing-guarantee certificate at Art. 6.12.6.

Spanish source (Guatemala). Translation: "There are two categories of modifications to the Health Inscription, those requiring a notification and those needing an authorisation from THE DEPARTMENT, per Form F-AS-f-10 of the current version Application for Update of Health Inscription of Related Products." The same chapter adds: 'Cuando se realicen cambios en los dispositivos médicos, el interesado debe solicitar su aprobación a la autoridad adjuntando los requisitos para el trámite de las modificaciones que se enumeran a continuación.'

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Device clinical-investigation authorisation: the device-specific dossier under AM 206-2021

clinical-investigation.device-trial-authorisation-dossier
Fact-level verified

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, investigator, CRO or SMO must file a device-specific dossier: general information (generic name, trade name, components and their detailed description, dimensional plan or design, additional substances, applicable national and foreign standards, international marketing evidence, sterility conditions, manufacturing/processing/packaging methods and controls, expiry or useful life, and any further information the nature of the equipment requires); information on the materials (manufacturer of each component, physical and chemical tests on raw materials, applicable standards, and functioning information including the mechanism of action, energy delivery to the patient, organs and tissues involved, area and mode of application, and interaction with other devices in contact with the patient); a copy of the device's Good Manufacturing Practice certificate issued in the country of origin with the corresponding legal formalities and a sworn translation where applicable; preclinical information; in vitro tests showing the absence of carcinogenic, teratogenic or other degenerative or adverse effects, with material characterisation, degradation products and exposure conditions; in vivo tests in experimental models; the consent letter signed by the directors of the health establishments; and a copy of the trial's insurance policy. The Department verifies within five calendar days that the application meets the requirements and notifies the applicant of its acceptance.

Conditions
  • Local authorisation is required before any investigation starts: numeral 5 requires the protocol to be authorised by the Department, with prior review and approval by an authorised independent ethics committee.
  • Numeral 30 provides that ethics committees are authorised by the Department for the review and approval of clinical trials 'with medicines and medical devices'.
  • Numeral 44.1 gives the Department five calendar days to verify that the application meets the requirements and to notify the applicant of acceptance; where it does not, the applicant must complete or correct it.

Spanish source (Guatemala). Verbatim opening of numeral 43: "43. Requisitos para solicitar autorización de un ensayo de dispositivo médico. El patrocinador, el investigador, CRO o SMO, deberá presentar la siguiente documentación referida al dispositivo médico". Translation: "Requirements for applying for authorisation of a medical-device trial. The sponsor, the investigator, CRO or SMO must present the following documentation relating to the medical device." Verbatim 43.3: "Copia del Certificado de Buena Práctica de Manufactura del dispositivo médico, emitida en el país de origen, cumpliendo los pases de ley correspondientes, con traducción jurada, si aplica." Translation: "Copy of the medical device's Good Manufacturing Practice Certificate, issued in the country of origin, meeting the corresponding legal formalities, with a sworn translation where applicable." Verbatim 43.5: "Ensayos in vitro. Se presentará información tendiente a demostrar que los dispositivos médicos no presentan efectos carcinogénicos, potencial teratogénico u otros efectos degenerativos sobre las células o tejidos, así como también efectos adversos." Translation: "In vitro tests. Information shall be presented tending to demonstrate that the medical devices present no carcinogenic effects, teratogenic potential or other degenerative effects on cells or tissues, nor adverse effects."

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition and the boundary with medicines

scope.device-definition-and-medicine-boundary
Fact-level verified

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 in its correct application, proposed by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; investigation, replacement, modification or support of anatomical structure or physiological process; diagnosis of pregnancy and control of conception; and care during pregnancy, birth or afterwards including care of the newborn. A product that achieves its purpose through chemical action in or on the body, or that is biotransformed during use, is a medicine and not a device; a device to which pharmacological properties are attributed by reason of its composition must be registered as a medicine. Absorbable sutures that biodegrade are nonetheless included within devices.

Conditions
  • NT-37 Art. 2 excludes products intended for the disinfection and sterilisation of medical devices and those listed in its Annex 2.
  • NT-37 Art. 4 integrates 'material de curación y material médico quirúrgico' into the medical-device line.

Spanish source (Guatemala). Translation: "3.1. Medical Device. A medical device for human use means any instrument, apparatus or other similar or related article, used alone or in combination, including its components, parts and accessories that take part in its correct application, proposed by the manufacturer for use in: 3.1.1. Diagnosis, prevention, monitoring, treatment or alleviation of a disease: [...] To establish the difference between a medicine and a medical device it must be borne in mind that a medical device does not achieve its purpose through chemical action in the body or on it and, further, is not biotransformed during use. A medical device to which pharmacological properties are attributed by reason of its composition must be registered as a medicine. Products such as absorbable sutures that do undergo biodegradation in the organism are included within medical devices." The bracketed elision covers sub-items 3.1.2–3.1.5, which are enumerated in the fact value.

IVD reagent definition and three risk categories

scope.ivd-definition-and-risk-categories
Fact-level verified

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 donations of blood, organs and tissues, principally to provide information on a physiological or pathological state, a congenital anomaly, the determination of the safety and compatibility of potential recipients, or the monitoring of therapeutic measures. IVDs are classified by health risk into Category I (low), Category II (medium) and Category III (high).

Conditions
  • Category III expressly includes reagents used to screen donors of blood, blood components and other tissues and organs for transplantation, reagents used to ensure immunological compatibility, and reagents for the diagnosis of communicable diseases of high risk to the life of the general population, including rapid tests.
  • Equipment for diagnosis — mechanical, electrical, electronic or logical instruments used for chemical, biological or immunological diagnostic purposes — is defined separately at NT-40 Art. 2.3.

Spanish source (Guatemala). Translation: "2.6 In vitro Diagnostic Reagent: a reactive product, calibrator, used alone or in association with others, intended for the study of samples proceeding from the human body, including donations of blood, organs and tissues, principally in order to provide information relating to: 2.6.1 A physiological or pathological state. 2.6.2 A congenital anomaly. 2.6.3 The determination of the safety and compatibility of potential recipients. 2.6.4 The monitoring of therapeutic measures." Art. 3 of the same norm establishes the three categories.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Closed 13-item dossier for device inscription

dossier.inscription-requirement-list
Fact-level verified

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 signed, sealed and stamped by a Químico Farmacéutico; finished-product specifications in Spanish; a product description in Spanish; the origin-country Certificate of Free Sale; a GMP certificate or other equivalent sanitary norm; an authenticated copy of the manufacturer's power of representation; analytical methodology where applicable; a quality-control certificate issued by the manufacturing laboratory; original primary and/or secondary packaging or readable drafts, with photocopies and overlaid labels not accepted; sealed samples according to the National Health Laboratory quantity list where applicable; technical literature, catalogue or insert in Spanish where applicable; and a photocopy of the registering establishment's sanitary licence.

Conditions
  • The file is submitted 'en fólder color natural y gancho' — a natural-coloured folder with a clip; trámite 3361 repeats this as 'Folder color natural'.
  • Foreign documents must satisfy Guatemalan legal requirements; documents in another language must be translated by a sworn translator authorised in Guatemala.
  • Documents presented without an expiry date are accepted for at most two years from issue.

Spanish source (Guatemala). Translation: "5.1.1 Proof of payment of the health inscription procedure fee, which also covers sanitary surveillance. 5.1.2 Health inscription application F-AS-f-08, signed, sealed and stamped by the professional Pharmacist Chemist. [...] 5.1.10 Original primary and/or secondary packaging or readable drafts. Photocopies and overlaid labels are not accepted. 5.1.11 Sealed samples (per the LNS quantity list), where applicable. 5.1.12 Technical literature for the product, catalogue or insert (in Spanish), where applicable. 5.1.13 Simple photocopy of the health licence of the registering establishment." Items 5.1.3–5.1.9 are elided in the excerpt and are enumerated in the fact value.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Only establishments licensed as importers may import devices

operator.import-only-by-licensed-establishments
Fact-level verified

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. Unlicensed operators cannot place devices on the Guatemalan market.

Conditions
  • An importer must maintain a technical director and legal representative who guarantee quality (AG 712-99 Art. 52, third paragraph).

Spanish source (Guatemala). Translation: "Without prejudice to other requirements established by law or regulation, the products mentioned in Article 1 of this Regulation may be imported only when they are registered or inscribed, as applicable, before THE DEPARTMENT. Only pharmaceutical and related-product establishments holding a current sanitary licence as importer may import."

Application must be signed by a local Químico Farmacéutico and accompanied by the manufacturer's power of representation

operator.local-pharmacist-signature-and-representation
Fact-level verified

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 of representation. For IVDs the signature may be given by a Químico Farmacéutico or Químico Biólogo. A Guatemalan-licensed professional and an appointed representative are therefore necessary parties to the filing.

Conditions
  • Documents issued abroad must satisfy Guatemalan legal requirements, and documents in a language other than Spanish must be translated by a sworn translator authorised in Guatemala (NT-37 Art. 5.2.4–5.2.5).

Spanish source (Guatemala). Translation: "5.1.2 Health inscription application F-AS-f-08, signed, sealed and stamped by the professional Pharmacist Chemist. [...] 5.1.7 Authenticated photocopy of the manufacturer's Power of Representation." NT-40 Art. 4.1.2 states the IVD equivalent: 'Solicitud de inscripción sanitaria, firmada, sellada y timbrada por el profesional Químico Farmacéutico o Químico Biólogo.'

The registering establishment must itself hold a sanitary licence

operator.registrant-must-hold-sanitary-licence
Fact-level verified

The establishment that registers the device must hold a sanitary licence issued under AG 712-99; a simple photocopy of that licence is a required element of the inscription dossier. The national trámites record adds that the principal distributor or droguería and any additional distributors or droguerías must also hold a current sanitary licence.

Conditions
  • The requirement attaches to the local registrant/establishment, not to the foreign manufacturer.

Spanish source (Guatemala). Translation: "5.1.13 Simple photocopy of the health licence of the registering establishment." Corroborated on trámite 3361, requirement 13: 'El Distribuidor o Droguería Principal y los Distribuidores o Droguerías Adicionales deberán contar con Licencia Sanitaria vigente.'

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Twenty licensed establishment classes include device factories, IVD factories, droguerías and distributors

establishment.sanitary-licence-classes-for-devices
Fact-level verified

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 diagnóstico' (71.9), 'Droguería' (71.11) and 'Distribuidora' (71.12). Article 72 makes a sanitary licence mandatory for all of them and subjects them to inspection by the DRCPFA.

Conditions
  • The licence is issued by the DRCPFA under Arts. 70–72 of AG 712-99.

Spanish source (Guatemala). Translation: "71.8) Factory of healing material and others. 71.9) Factory of diagnostic reagents. [...] ARTICLE 72. ON THE SANITARY LICENCE OF PHARMACEUTICAL ESTABLISHMENTS. All establishments listed in the previous article must hold a sanitary licence." Square brackets mark an elision of the intervening classes 71.10–71.20.

Fees

What regulator fee applies to this class, route, event, and date?

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Published fee for the device inscription procedure is Q 100

fees.device-inscription-fee
Fact-level verified

The published cost of the medical-device sanitary inscription procedure is Q 100 (one hundred quetzales). The same amount is shown for the renewal variant of the procedure.

Conditions
  • Fees are fixed by the aranceles schedule (Acuerdo Gubernativo 53-2022) and paid through payment slip V-CC-G-001; the MSPAS aranceles summary places device inscription in the 'Productos Afines' block under INSCRIPCION SANITARIA (Nuevo y Renovación).
  • Planning figure: under the registry review policy a government fee remains an estimate and is due for re-verification after 12 months.

Spanish source (Guatemala). Translation: "Cost: Q 100." The trámites record 3362 (renewal without change of formula) shows the same 'Costo: Q 100'. For comparison, the pharmaceutical-only routes on the same portal are Q 130 for homologation (trámite 3495) and Q 750 for mutual recognition (trámite 3502); neither is open to devices.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Instructions for use and warnings must appear in Spanish on imported devices

label.spanish-required-for-use-instructions
Fact-level verified

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 applies to IVD labelling. Documents in a language other than Spanish must be translated by a sworn translator authorised in Guatemala.

Conditions
  • Label elements for devices are listed at NT-37 Art. 7.1 (secondary packaging) and Art. 7.2 (primary packaging): product name, batch number, expiry date, inscription number, 'Estéril' where applicable, measurements and storage temperature where applicable.
  • Documents presented without an expiry date are accepted for at most two years from issue (NT-37 Art. 5.2.6).

Spanish source (Guatemala). Translation: "7.1.2. Mode of use or instructions for use and warnings. For imported products, the information requested in this item must appear in Spanish." Reinforced by NT-37 Art. 5.2.5: 'Los escritos en idioma distinto al español deben ser traducidos por traductor jurado autorizado en la República de Guatemala.' The IVD equivalent is NT-40 Art. 9.1.2 and 9.2.3: 'Para productos importados, la información solicitada en esta literal debe aparecer en idioma español.'

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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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

pms.nt-19-2009-post-market-obligations-address-medicine-marketers-only
Fact-level verified

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 serious suspected reactions to the National Coordinating Centre immediately and in any case within fifteen calendar days, submit periodic safety reports, run pharmacovigilance and risk-management plans, and (Art. 10) keep a permanently available qualified professional responsible for pharmacovigilance. Devices appear only in Art. 2.2, where 'ensayo clínico' includes experimental evaluation of a 'dispositivo'. The norm therefore does not itself create a manufacturer post-market surveillance duty for medical devices.

Conditions
  • The instrument was read in full (7 scanned pages, viewed as images).
  • This is a bounded observation about NT 19-2009 only; the tecnovigilancia form and plan checklist show that the Programme operates device surveillance administratively.

Effective from 2009-08-24

Spanish. Gist: Art. 9 obliges the company authorised to market medicines to keep an ADR register and to report serious suspected ADRs to the National Coordinating Centre immediately and within 15 calendar days; Art. 2.2 defines a clinical trial as experimental evaluation of a substance, medicine or device in humans. Transcribed from the scanned pages (pages 2, 4 and 5).

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

pms.tecnovigilancia-notification-form-f-fv-c-04-and-channel
Fact-level verified

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 farmacovigilanciadrcpfa@mspas.gob.gt or presented at the window of the Dirección de Regulación, Vigilancia y Control de la Salud, Avenida Bolívar 28-07 zona 8, Guatemala; the form states that notification lets the Programme collect information on the effectiveness of medical devices used in medical and surgical settings, and asks for any relevant attachments such as photographs, contracts or letters.

Conditions
  • The form is addressed to any notifier (patient data, institution, device data, event, notifier data); it is not limited to manufacturers or holders of the inscripción sanitaria.
  • The DRCPFA services page separately directs tecnovigilancia notifications, with the form's requirements, to the Farmacovigilancia y Ensayos Clínicos office at 3a calle final 2-10, zona 15.
  • No reporting deadline for devices is stated on the form or the services page.

Spanish. Gist: F-FV-c-04 v03-2025 Tecnovigilance Notification Form; send to farmacovigilanciadrcpfa@mspas.gob.gt; notification lets the National Pharmacovigilance Programme gather information on the effectiveness of medical devices used in medical and surgical practice; may be completed digitally or by hand; present at the DRVCS window, Avenida Bolívar 28-07 zona 8, or by the e-mail given.

A tecnovigilancia report must identify the device (generic name, lot, brand, model, expiry) and its número de inscripción sanitaria, classify the event as adverse event or quality failure, and record the outcome

pms.tecnovigilancia-report-content-device-identity-inscription-number-event-outcome
Fact-level verified

Section 3 of form F-FV-c-04 requires the device's generic name, lot number, brand, model, sanitary inscription number (marked in the instructions as indispensable), place of purchase and expiry date; section 4 requires a description of the adverse event or quality failure, the notification type (evento adverso, falla de calidad, otro), the body area and the outcome (recovered with sequelae, required medical or surgical intervention, life-threatening, malformation, no harm, unknown, death with date).

Conditions
  • Data on the form are declared confidential.
  • The sanitary inscription number field ties every report to the registered device, but no duty on the inscription holder to investigate or respond is written on the form.

Spanish. Gist: device data (generic name, lot, brand, model, sanitary inscription number, where obtained, expiry) and event data (description of adverse event or quality failure, notification type, body area, outcome options including death); the instructions call the inscription number indispensable.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Current inscription and update forms (F-AS-f-08 V 24-2025, F-AS-f-10 V 13-2025)

forms.inscription-and-update-forms
Fact-level verified
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 into force on 2 February 2026 (version V 23-2025, entering into force 6 November 2025, is the immediately preceding one, still listed on the same index); updates to an inscription are applied for on form F-AS-f-10, 'Solicitud de Actualización de Inscripción Sanitaria de Productos Afines', version V 13-2025, entering into force 6 November 2025. All are published on the DRCPFA's 'Formularios de Inscripción Sanitaria' index and downloaded from it.

Conditions
  • Version V 24-2025 of F-AS-f-08 took effect 2026-02-02; the superseded version V 23-2025 is still listed on the index.

Effective from 2026-02-02

Spanish source (Guatemala). What this round verified that round 204 could not: the form version in force and its effective date, read off the forms index itself — round 204's row recorded the form numbers from the same landing page but noted that the version in force was not established. Translation: "Health Inscription Forms | F-AS-f-08 V 24-2025 | Application for Health Inscription of Related Products | Enters into force 2 February 2026 | F-AS-f-08 V 23-2025 | Application for Health Inscription of Related Products | Enters into force 6 November 2025 | F-AS-f-10 V 13-2025 | Application for Update of Health Inscription of Related Products | Enters into force 6 November 2025." This is a forms landing page whose locator names the forms, which the round-209 contract makes citable for D10.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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All device and IVD establishments are licensed and inspected by the DRCPFA

qms.establishment-licensing-and-inspection
Fact-level verified

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 licence and is subject to inspection by the DRCPFA, which must verify compliance with the Health Code, AG 712-99 and the technical procedures it approves. The same article extends inspection to supermarkets and shops selling over-the-counter pharmaceutical products.

Conditions
  • Separately, the inscription dossier requires a GMP certificate or equivalent sanitary norm for the manufacturing laboratory (NT-37 Art. 5.1.6), and manufacturing-guarantee certificates from named authorities are accepted (NT-37 Art. 6.12.6).

Spanish source (Guatemala). Translation: "All establishments listed in the previous article must hold a sanitary licence. These establishments, as well as supermarkets and shops where over-the-counter pharmaceutical products are sold, remain subject to inspection by THE DEPARTMENT, which must ensure compliance with the provisions of the Health Code, those of this Regulation and the technical procedures it approves."

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Public register of complaints, deviations and market withdrawals covering devices and IVDs

surveillance.withdrawal-and-deviation-alerts
Fact-level verified

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, afines y otros productos objeto de vigilancia sanitaria'. The register carries medical-device and in-vitro-diagnostic lines under their own sanitary registrations (PMQ- for devices, RD- for diagnostic reagents), each with the product, company, notification type, reason, lot, expiry and a completion status — for example the BD INSYTE-N AUTOGARD IV safety catheter (registration PMQ-6304, lot 4208538, withdrawn 04/09/2025 for complaints during insertion, status FINALIZADO) and the BD BACTEC MGIT 960 PZA KIT (registration RD-5685, lot 3191569, withdrawn 04/07/2025 for false negatives in pyrazinamide resistance testing, status FINALIZADO). A product found non-compliant in surveillance is therefore taken off the Guatemalan market through a published withdrawal notification that covers devices and IVDs, not only medicines.

Conditions
  • The April-2026 edition of the register is cumulative and lists entries with status FINALIZADO or still in process.
Alerta de Retiro o Desvíos de Productos del Mercado

Spanish source (Guatemala). What this round verified that round 204 could not: round 204 read only the DRCPFA alert index page and recorded the existence of the channel; this round read the alert register itself and found device (PMQ-) and IVD (RD-) lines in it, which is what makes the channel device-operational. The excerpt is quoted as the PDF's text layer lays it out: the register is set as a multi-line table, so a row's cells span several lines and the column header is split across three lines, which is why the passage reads in column order rather than strictly left to right. No cell wording has been altered. Translation of the title: "NOTIFICATIONS OF COMPLAINTS OR CLAIMS, DEVIATIONS (THEFTS) AND WITHDRAWAL OF PRODUCT FROM THE MARKET OF PHARMACEUTICAL PRODUCTS, RELATED PRODUCTS AND OTHER PRODUCTS SUBJECT TO SANITARY SURVEILLANCE"; of the columns: "Date | Product name | Company name | Notification type | Reason for the notification | Lot | Expiry date | Sanitary registration | Completion date"; of the device row: "04/09/2025 | BD INSYTE-N AUTOGARD, IV SAFETY CATHETER | Becton Dickinson | Withdrawal of product from the market | Withdrawal due to complaints during insertion of the catheter, the needle retracts slowly or does not retract | 4208538 | 31/07/2027 | PMQ-6304 | FINALISED"; and of the IVD row: "04/07/2025 | BD BACTEC MGIT 960 PZA KIT | Becton Dickinson | Withdrawal of product from the market | False negatives for pyrazinamide (PZA) resistance in diagnostic tests for tuberculosis | 3191569 | 06/10/2024 | RD-5685 | FINALISED".

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

IVDs take the same inscription route under their own norm, NT-40 v3-2015

pathways.ivd-inscription-under-nt40
Fact-level verified

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 abridged or recognition variant. IVDs are divided into three health-risk categories (I low, II medium, III high) that determine applicable requirements rather than the pathway.

Conditions
  • The IVD inscription is valid for five years from grant (NT-40 Art. 4.3).

Spanish source (Guatemala). Translation: "Article 1. Object. The object of this Technical Norm is to regulate the conditions and requirements under which the health inscription of in-vitro Diagnostic Reagents is granted." Art. 3 of the same norm sets the three risk categories.

One pre-market route for devices: Inscripción Sanitaria under NT-37 v5-2016

pathways.single-inscription-sanitaria-route
Fact-level verified

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 Inscripción Sanitaria. The national trámites catalogue records it as one procedure (3361) at Q 100, with no class-specific, accelerated or reference-authority variant; a device's class determines whether physicochemical and microbiological analysis is performed, not which pathway is used.

Conditions
  • The device's class (I–IV per Annex 1) drives whether the file goes for analysis, not the route itself.
  • Renewal runs on the same form and at the same published fee.

Spanish source (Guatemala). Translation: "Issuance of the Health Inscription Certificate for new Medical Device Reagents: the Health Inscription Certificate is the document issued by the MSPAS through the Section for Sanitary Authorisations of Related Products, recording that a Medical Device complies with all the requirements established in the technical norms in force, so that it may be imported and marketed in the Republic of Guatemala." The page also records normative 'DISPOSITIVOS MEDICOS: Norma Tecnica 37 version 5-2016', 'Resultado: Certificado de Inscripción Sanitaria', 'Costo: Q 100'.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Guatemala approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Guatemala (7 records)

GuatemalaUS FDA · ISO

Prior approval / evidence record

A US FDA, DGKC or IFCC credential can satisfy the manufacturing-guarantee dossier item

reliance.foreign-authority-manufacturing-guarantee
Fact-level verified
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 Manufacturing Practices, Standards Approval, an ISO certificate, the US FDA, the DGKC or the IFCC. A US FDA or comparable foreign credential can therefore satisfy this dossier item — as evidence, not as an approval that replaces the inscription.

Source Approval

US FDA; DGKC (German Society for Clinical Chemistry); IFCC (International Federation of Clinical Chemistry and Laboratory Medicine); ISO certificate; GMP or standards-approval certificate from a health authority

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • This wording sits in the modification chapter (Art. 6.12, addition of an alternative manufacturing plant); the general inscription dossier requirement for a GMP certificate or equivalent sanitary norm is Art. 5.1.6.
  • The same wording is reproduced as requirement 6 of the national trámites record 3361.
  • Evidence-only: the named foreign credentials satisfy a dossier item and do not open an abridged route or substitute for the local decision.

Spanish source (Guatemala). Translation: "6.12.6 Manufacturing guarantee certificate issued by the health authority (Good Manufacturing Practices, Standards Approval, ISO certificate, FDA, DGKC or IFCC: International Federation of Clinical Chemistry and Laboratory Medicine)." Reproduced verbatim on the national trámites record 3361 as requirement 6: 'Certificado original de garantía de manufactura emitido por la autoridad sanitaria (BPM, Aprobación de normas, certificado ISO 9001, FDA, DGKC ó IFCC).' NT-40 Art. 4.1.5 applies the same idea to IVDs: 'Certificado original de garantía de manufactura emitido por la autoridad sanitaria (BPM, Certificado ISO 9001, FDA, DGKC ó IFCC).'

GuatemalaSource authority not specified

Prior approval / evidence record

The mutual-recognition registration procedure is restricted to medicines for human use

reliance.mutual-recognition-tramite-is-medicines-only
Fact-level verified
Statement

Guatemala's national trámites catalogue records a mutual-recognition registration procedure ('Registro Sanitario Nuevo Reconocimiento Mutuo', trámite 3502, Q 750, 10 working days). Its application form is expressly for the mutual recognition of the health registration of medicines for human use, to be filed before the Regulatory Authorities of the States Party. No device or IVD equivalent exists in the catalogue; the companion homologation procedure (trámite 3495) is likewise pharmaceutical-only.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The mutual-recognition route is built on RTCA 11.03.59:18 Annex II, Resolución No. 446-2021 (COMIECO-XCIV) and is limited to medicines for human use.
  • The homologation route (trámite 3495) requires an original WHO-type Certificate of Pharmaceutical Product from a high-maturity authority and is likewise limited to pharmaceutical products.

Spanish source (Guatemala). Translation: "Application (Form F-AS-f-16, current version) for the mutual recognition of the health registration of medicines for human use, signed and sealed by the Responsible Professional and the Holder or Legal Representative, before the Regulatory Authorities of the States Party." The same page records 'Resultado: Certificado de Registro Sanitario', 'Costo: Q 750' and 'Tiempo de Respuesta: 10 días hábiles'. The homologation page (trámite 3495) records 'Resultado: Certificado de Registro Sanitario', 'Costo: Q 130', 'Tiempo de Respuesta: 45 días hábiles', normative 'Norma Técnica 77, versión vigente' and the requirement 'Si es importado: Certificado de Producto Farmacéutico (CPP) original, tipo OMS, vigente, emitido por autoridad reguladora de lata madurez y desempeño' [sic — the page reads 'lata' for 'alta'].

GuatemalaCentral American Customs Union

Prior approval / evidence record

PAHO/PARF regional reference authorities (ARNr) and COMIECO member states

Authority

PAHO/PARF regional reference authorities (ARNr) and COMIECO member states

Accepted

No

Benefit

No 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.

Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuestaNorma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Arts. 5, 8, 9 y Anexo 1Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Arts. 3 y 4.3Norma Técnica 77 versión 8-2023 — homologation on a WHO-listed authority registration, Art. 2 (scope: chemical-synthesis medicines and vaccines only)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GuatemalaWHO · US FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS

Prior approval / evidence record

Homologation on a WHO-listed-authority approval exists but is scoped to medicines and vaccines, not devices

reliance.homologation-who-listed-authority-medicines-vaccines-only
Fact-level verified
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 of high maturity and performance (WLA/ACO, ML3+). Article 2 confines that route expressly to pharmaceutical specialities of chemical synthesis and to vaccines (biological and biotechnological). It does not reach medical devices or in vitro diagnostics.

Source Approval

Approval by a WHO-listed authority (WLA/ACO, maturity level 3 or above) — e.g. US FDA, EMA, Japan PMDA, Korea MFDS — for chemical-synthesis medicines and vaccines only

Edge Type

Abridged Or Recognition Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Scope limited to especialidades farmacéuticas de síntesis química and vacunas (biológicas y biotecnológicas).
  • Not available for medical devices or IVDs; marketAccessStrength is 'none' for those domains because the route exists but gives them nothing.
  • The WHO-listed authorities eligible are those published in the DRCPFA's own official lists.

Spanish source (Guatemala). Translation: "Article 2. Scope of application. This Technical Norm applies to pharmaceutical specialities of chemical synthesis and vaccines (biological and biotechnological) that hold a Health Registration granted by high-maturity-and-performance Regulatory Authorities as defined by the World Health Organization (WHO), published in the official lists of the Department of Regulation and Control of Pharmaceutical and Related Products, hereinafter THE DEPARTMENT." The norm's own title is 'HOMOLOGACIÓN DEL REGISTRO SANITARIO DE MEDICAMENTOS Y VACUNAS'. Art. 4.3 of the same norm defines the WLA/ACO concept and states that authorities reaching at least general maturity level 3 (ML3) qualify.

GuatemalaSource authority not specified

Prior approval / evidence record

Origin-country Certificate of Free Sale is a mandatory dossier item but opens no shortened route

reliance.origin-country-free-sale-certificate
Fact-level verified
Statement

A Certificate of Free Sale issued by the competent health authority of the country of origin is a mandatory element of every device inscription dossier. It is evidence of the product's status abroad and is required paperwork, but it neither shortens nor replaces the Guatemalan evaluation; the full local review still runs.

Source Approval

Marketing authorisation or free-sale certificate from any competent health authority of the country of origin; no specific authority (FDA, CE, PMDA, MFDS) is privileged

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The certificate must be valid on the day the file is submitted at the window; documents presented without an expiry date are accepted for at most two years from issue (NT-37 Art. 5.2.6).
  • An original may be replaced by a notarially legalised photocopy (NT-37 Art. 5.2.1).
  • Documents issued abroad must satisfy Guatemalan legal requirements to be valid (NT-37 Art. 5.2.4).
  • For a first registration under trámite 3361 the requirement is worded: 'Cuando el origen es extranjero: Certificado de venta libre del país de origen.'

Spanish source (Guatemala). Translation: "5.1.5 Certificate of Free Sale of the country of origin issued by the competent HEALTH authority." Corroborated on the national trámites record 3361, requirement 7: 'Cuando el origen es extranjero: Certificado de venta libre del país de origen.' The obligation is evidentiary only: no article makes the foreign certificate a substitute for the local inscription.

GuatemalaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS

Prior approval / evidence record

WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)

Authority

WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)

Accepted

No

Benefit

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.

Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuestaNorma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Arts. 5, 8, 9 y Anexo 1Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Arts. 3 y 4.3Norma Técnica 77 versión 8-2023 — homologation on a WHO-listed authority registration, Art. 2 (scope: chemical-synthesis medicines and vaccines only)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

GuatemalaSource authority not specified

Prior approval / evidence record

Central American harmonisation and mutual recognition covers no device or IVD RTCA

reliance.no-central-american-device-rtca
Fact-level verified
Statement

The Central American harmonisation instruments that Guatemala publishes under its COMIECO/RTCA index cover medicines, natural medicinal products, cosmetics, hygiene products and pesticides. None addresses medical devices or IVDs, and the COMIECO mutual recognition of health registrations is confined by its own annex to pharmaceutical products originating in the member countries of the customs union.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Regional Harmonisation

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • COMIECO Resolución 93-2002 (published in Guatemala by Acuerdo 506-2002) provides mutual recognition of pharmaceutical registrations among El Salvador, Honduras and Nicaragua only, only for products originating in the States Party, and its numeral 3 states it is not applicable in Costa Rica and Guatemala.
  • The claim that the MSPAS RTCA index covers only natural medicinal products (2024), cosmetics (2024), hygiene products (2008) and pesticides (2010) needs the normas-index page (r209-gt-mspas-normas-index) added as a second source or should be dropped from this fact.

Spanish source (Guatemala). Translation: "This procedure for the recognition of the health registration of pharmaceutical products shall apply only to products originating in the member countries of the Customs Union." The operative clause of the same instrument reads: "El Salvador, Honduras y Nicaragua acuerdan el reconocimiento entre sí de los registros sanitarios de productos farmacéuticos que estén vigentes en dichos países antes del perfeccionamiento de la Unión Aduanera." Guatemala is not a party to that recognition; the instrument is limited to pharmaceutical products in any event. The absence of any device RTCA was checked against the MSPAS COMIECO/RTCA index page, which lists 27 instruments and returns no occurrence of 'dispositiv'.

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Published response times: 20 working days new, 15 working days renewal

clocks.device-inscription-and-renewal-clocks
Fact-level verified

The published response time for the medical-device inscription procedure is 20 working days for new inscriptions and 15 working days for renewals.

Conditions
  • Planning figure only: under the registry review policy a regulator review clock remains an estimate and is due for re-verification after 12 months.
  • The clock is published on the national trámites record, not in NT-37 itself.

Spanish source (Guatemala). Translation: "Response time: NEW: 20 working days. RENEWALS: 15 working days." For comparison, the pharmaceutical-only routes on the same portal quote 45 working days for homologation (trámite 3495) and 10 working days for mutual recognition (trámite 3502).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Compassionate use: definition covering medical devices and the Department's authorisation route

special-access.compassionate-use-authorisation
Fact-level verified

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 indications or conditions of use other than those authorised, under the exclusive responsibility of a physician who considers its use indispensable. To use a product as compassionate use under the conditions of the original clinical trial, a utilisation protocol prepared by the requesting physician is required, with the patient's or their representative's informed consent, a clinical report in which the physician justifies the need for the treatment, where applicable the conformity of the director of the centre where the treatment is to be administered, and the authorisation of the Department. The application to the Department must attach the clinical report and justification of the responsible specialist physician, the medical director's approval where applicable, the patient's informed consent, a bibliographic review of the product, and the reasons the patient cannot be included in an authorised clinical trial. The Department authorises the compassionate use on the documentation presented, and compassionate treatments cannot be dispensed on prescription because the product is not registered in the country.

Conditions
  • The definitional limb expressly names 'medicamento o dispositivo médico'; the procedural limb (numeral 65) is drafted around 'un producto' and its closing sentence refers to the medicine as unregistered — so the device footing rests on the definition, and the procedure is applied to the product.

Spanish source (Guatemala). Verbatim 4.122: "Uso compasivo. Utilización de un medicamento o dispositivo médico en pacientes aislados, al margen de un ensayo clínico. Se incluyen las especialidades farmacéuticas para indicaciones o condiciones de uso diferentes a las autorizadas, bajo la responsabilidad exclusiva de un médico que considere indispensable su utilización." Translation: "Compassionate use. Use of a medicine or medical device in isolated patients, outside a clinical trial. It includes pharmaceutical specialities for indications or conditions of use different from those authorised, under the exclusive responsibility of a physician who considers its use indispensable." Verbatim 65: "Uso compasivo de productos. Para utilizar un producto como uso compasivo bajo las condiciones del ensayo clínico original, se requerirá de un protocolo de utilización elaborado por el médico solicitante; consentimiento informado del paciente o su representante; informe clínico en el que el médico justifique la necesidad de dicho tratamiento; cuando aplique, la conformidad del director del centro donde se vaya a administrar el tratamiento y, la autorización de El Departamento." Translation: "Compassionate use of products. To use a product as compassionate use under the conditions of the original clinical trial, a utilisation protocol prepared by the requesting physician will be required; informed consent of the patient or their representative; a clinical report in which the physician justifies the need for that treatment; where applicable, the conformity of the director of the centre where the treatment is to be administered; and the authorisation of The Department."

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Positive administrative silence for certifications, authorisations and opinions

submission.deemed-favourable-decision-on-authority-delay
Fact-level verified

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 regulations, does not issue it within the periods established for that purpose. For an applicant for a device or IVD inscription or authorisation, the practical effect is that a decision not taken within the prescribed period is treated as a favourable one.

Conditions
  • Art. 241 sits in the Código de Salud's final provisions, so it is a general health-law rule applying to MSPAS/DRCPFA procedures; the specific periods are fixed by the particular instrument, and this fact does not establish any of them.

Spanish source (Guatemala). Verbatim: "Se darán por resueltas favorablemente todas aquellas peticiones que impliquen la emisión de una certificación, autorización, o dictamen, cuando la autoridad competente de conformidad con esta ley y sus reglamentos, no la emitiera dentro de los plazos establecidos para esos efectos." Translation: "All petitions that involve the issuance of a certification, authorisation or opinion shall be deemed resolved favourably where the competent authority, in accordance with this law and its regulations, does not issue it within the periods established for those purposes."

Deficiency note, remedy of non-conformities and closure of the application

submission.deficiency-note-remedy-and-closure
Fact-level verified

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 (LNS); the Department evaluates the application and asks whether it complies; where it does not, a deficiency note ('se envía nota de reparo') is sent and the applicant remedies the non-conformities ('subsana inconformidades'); where an LNS analysis is required and the analysis does not comply, the application is closed ('se da de baja a la solicitud'), and where it does comply the Inscription Certificate is issued and passed to the Documents Reception and Delivery section for collection.

Conditions
  • The procedure covers inscription files for 'productos afines', the category under which device and IVD inscription runs at the DRCPFA.
  • The National Health Laboratory analysis branch applies only to products that require LNS analysis — hospital hygiene products and sunscreens, per the procedure's own footnote.

Spanish source (Guatemala). The procedure is published by the DRCPFA as the flowchart F-AA-p-01, "Procedimiento de ingreso y evaluación de expedientes para la autorización de inscripciones sanitarias de productos afines". The excerpt quotes the diagram as the PDF's text layer lays it out, so the lane labels of the three swimlanes appear in column order; no wording has been altered. Verbatim stage labels: "Se evalúa la solicitud." / "¿Cumple?" / "No" / "Se envía nota de reparo" / "SI" / "Subsana inconformidades" / "Espera el resultado de análisis del LNS." / "¿Análisis de LNS cumple?" / "Se da de baja a la solicitud." / "Se emite Certificación y se traslada a Recepción y Entrega de Documentos." Translation: "The application is evaluated." / "Does it comply?" / "No" / "A deficiency note is sent" / "YES" / "Remedies the non-conformities" / "Awaits the result of the LNS analysis." / "Does the LNS analysis comply?" / "The application is closed." / "The Certificate is issued and passed to Documents Reception and Delivery." The procedure's own footnote states: "Las actividades marcadas en color celeste únicamente corresponden a los productos que requieren análisis de LNS, es decir, productos higiénicos hospitalarios y bloqueadores solares." ("The activities marked in light blue correspond only to the products that require LNS analysis, that is, hospital hygiene products and sunscreens.")

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Customs release conditioned on DRCPFA-authorised import documents carrying the registration number

traceability.import-documents-carry-the-inscription-number
Fact-level verified

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 permitted only if the product is registered or inscribed with the DRCPFA and only through establishments holding a current sanitary importer licence. The customs policies and forms (pólizas y formularios aduaneros) must be submitted to the DRCPFA for authorisation beforehand, and before that authorisation they must be signed and sealed by the establishment's technical director, with the corresponding registration or inscription number(s) appearing on the invoices attached to those documents. The customs authorities of the Republic admit only products duly registered or inscribed.

Conditions
  • AG 712-99 Art. 1 covers medicines, narcotics and precursors, herbal products, cosmetics, hygiene and household products, domestic pesticides, material de curación, laboratory diagnostic reagents, and dental products and equipment; Art. 42.3 and 42.4 classify 'material de curación y material médico quirúrgico' and 'reactivos de laboratorio para diagnóstico' as related products under control. This is the listing/traceability duty that exists; no UDI duty was found (see the note).

Spanish source (Guatemala). Translation of Art. 52 in part: "Importation. Without prejudice to other legally or regulatorily established requirements, only the products mentioned in article 1 of this Regulation may be imported when they are registered or inscribed, as applicable, with THE DEPARTMENT. Only pharmaceutical and related-product establishments holding a current sanitary licence as importer may import. […] The customs authorities of the Republic shall only permit the importation of the products enumerated in Article 1 of this Regulation that are duly registered or inscribed as applicable. To comply with the foregoing, the customs policies and forms must be presented beforehand, for their authorisation, to THE DEPARTMENT." Translation of Art. 54: "Import policies and forms for pharmaceutical and related products, prior to their authorisation by THE DEPARTMENT, save the exceptions mentioned in Article 33 of this Regulation, must be signed and sealed by the technical director of the establishment, and the corresponding registration or inscription number(s) must appear on the invoices attached to these documents." Search result recorded for the dimension: no UDI provision was found in AG 712-99, in the Código de Salud (Decreto 90-97) or in Acuerdo Ministerial 206-2021; the device and IVD inscription norms (NT 37 versión 5-2016, NT 40) are image-only scans and were not read, and no separate UDI instrument appears in the DRCPFA normative register.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Adverse device incidents must be notified by all health personnel

vigilance.adverse-incident-notification-obligation
Fact-level verified

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, therapeutic failure, adverse reactions to medicines and adverse incidents in medical devices within the health services network. Notification is an obligation of all medical, paramedical and other health professionals.

Conditions
  • The obligation as drafted falls on health personnel of the Red de Servicios de Salud, with notification criteria set by the Junta Técnica de Valoración and by Farmacovigilancia.
  • The instrument is filed on the MSPAS agreements page as 'AG 418-2014' but its own header reads 'ACUERDO MINISTERIAL No. 418-2014'.

Spanish source (Guatemala). Translation: "Article 1. Object. To establish the procedure for Notification by Suspicion of Quality Non-compliance, Therapeutic Failure or Adverse Reactions of Medicines and Adverse Incidents in Medical Devices for the Health Services Network. Article 2. Nature of the notification. The identification and notification by suspicion of quality non-compliance, therapeutic failure or adverse reactions of medicines and adverse incidents in medical devices is an obligation of all medical, paramedical and other health professionals, in accordance with the Basic Notification Criteria established by the Technical Assessment Board and by Pharmacovigilance."

Related structured datasets

Classification systems · 2 records
Open Categorías I, II y III — NT-40 versión 3-2015, Art. 3 →
Id

guatemala:ivd

Jurisdiction Id

guatemala

Domains
  • ivd
Notes
  • NT-40 Art. 3.2 defines Category II as the residual class — reagents not in Category I or III that relate to the listed areas — so a reagent with no other match falls to Category II rather than Category I.
  • NT-40 Art. 2.3 defines 'equipo para diagnóstico' (mechanical, electrical, electronic or logical instruments used for diagnostic reading) separately from the reagent, so an analyser is not classified as an IVD reagent by this norm.
  • All components of a reagent family — reagents, calibrators, controls and buffers or solutions used for the same purpose — share one inscription and one category (NT-40 Art. 1).
Name

Categorías I, II y III — NT-40 versión 3-2015, Art. 3

Description

In vitro diagnostic reagents have their own class axis, set by Norma Técnica Número 40 versión 3-2015 Art. 3, which classifies by sanitary risk taking into account knowledge, training, technology, analysis and the impact of the result. Category I is an enumerated low-risk list (culture media, colorants, diluents, buffers and lysing agents, wash solutions); Category II is a residual medium-risk category covering molecular biology, endocrinology, toxicopharmacology, blood chemistry, haematology, immunology, microbiology, copro-parasitology, coagulation, blood gases, urinalysis, immuno-haematology screening cells and self-testing; Category III is high risk (donor and transplant screening, immunological compatibility of blood, tissues and organs, and communicable diseases of high risk to the life of the general population, including rapid tests).

Classes
  • Id

    categoria-i

    Label

    Categoría I — Bajo Riesgo

    Normalized Risk Level

    low

  • Id

    categoria-ii

    Label

    Categoría II — Mediano Riesgo

    Normalized Risk Level

    medium

  • Id

    categoria-iii

    Label

    Categoría III — Alto Riesgo

    Normalized Risk Level

    high

Regulator

MSPAS

Official Domains
  • medicamentos.mspas.gob.gt
  • tramites.gob.gt
Source Status

official-source-verified

Reference Sources
  • Title

    Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro (normativa NT-40 v3-2015)

    Url

    https://www.tramites.gob.gt/servicio/3357/

    Reviewed On

    2026-09-16

    Supports

    The IVD inscription is a separate trámite from the device inscription, is governed expressly by NT-40 v3-2015, and is filed in a black folder; the record publishes the same 20-working-day new and 15-working-day renewal clocks as the device trámite.

Source Title

Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Art. 3

Source Url

https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=234:nt40

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open Clases I, II, III y IV — NT-37 versión 5-2016, Anexo 1 →
Id

guatemala:medical-device

Jurisdiction Id

guatemala

Domains
  • medical-device
Notes
  • NT-37 Art. 12 states only the two axes (uso in vivo / según su clase) and refers to Anexo 1 for the classes; the four class names and their sterility-and-use criteria were read from the Anexo 1 page image of the scanned norm.
  • Anexo 2 of the same norm is a separate list headed 'EQUIPO MEDICO QUE NO REQUIERE INSCRIPCION', so not every article that meets the Art. 3.1 device definition needs an inscription.
  • Class is a dossier-routing fact, not a fee fact: the arancel charges one flat item per inscription file whatever the class, and trámite 3361 step 2 records that laboratory analysis is not currently required for any device file.
Name

Clases I, II, III y IV — NT-37 versión 5-2016, Anexo 1

Description

Guatemala's own device class axis: Norma Técnica Número 37 versión 5-2016 classifies medical devices by use (in vivo) and by class, and Anexo 1 assigns the class from the combination of sterility and external or internal use. Class drives whether the inscription file goes for laboratory analysis, not which route it takes — there is a single Inscripción Sanitaria route for all four classes.

Classes
  • Id

    i

    Label

    Clase I — inscripción sin análisis (no estéril de uso externo)

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Clase II — inscripción con análisis (estéril de uso externo)

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Clase III — inscripción con análisis (no estéril de uso interno)

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Clase IV — inscripción con análisis (estéril de uso interno)

    Normalized Risk Level

    highest

Regulator

MSPAS

Official Domains
  • medicamentos.mspas.gob.gt
  • tramites.gob.gt
Source Status

official-source-verified

Reference Sources
  • Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Reviewed On

    2026-09-16

    Supports

    The operational classification step: the file is received by the Sección de Recepción y Entrega de Documentos and routed to the Sección de Autorizaciones Sanitarias de Productos Afines, which classifies and evaluates it; step 2 records that laboratory analysis is not currently required, so the Anexo 1 analysis/no-analysis split currently changes nothing on the ground.

Source Title

Norma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Art. 12 y Anexo 1

Source Url

https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=262:inscripcion-sanitaria-de-dispositivos-medicos

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Guatemala registration →
Country

Guatemala

Jurisdiction Id

guatemala

Country Code

GT

Flag

🇬🇹

Regulator

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

Regulator Abbrev

MSPAS

Region

americas

Tier

3

Risk Classification

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)

Classes
  • Id

    device-class-i-inscription

    Class Name

    Clase I — inscription without analysis (non-sterile, external use)

    Risk Level

    low

    Pathway

    Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA in a natural-coloured folder

    Official Timeline
    Min

    20

    Max

    20

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    device-class-ii-iv-inscription

    Class Name

    Clases II, III and IV — inscription with analysis

    Risk Level

    high

    Pathway

    Inscripción Sanitaria under NT-37 v5-2016, filed on form F-AS-f-08 with the DRCPFA

    Official Timeline
    Min

    20

    Max

    20

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    3

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    device-renewal

    Class Name

    Renovación de la Inscripción Sanitaria (all classes)

    Pathway

    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

    Official Timeline
    Min

    15

    Max

    15

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    ivd-inscription

    Class Name

    IVD reagent — new inscription (Categorías I, II and III)

    Risk Level

    medium

    Pathway

    Inscripción Sanitaria under NT-40 v3-2015, filed with the DRCPFA in a black folder

    Official Timeline
    Min

    20

    Max

    20

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuesta

    Url

    https://www.tramites.gob.gt/servicio/3357/

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    ivd-renewal

    Class Name

    IVD reagent — renewal (Categorías I, II and III)

    Pathway

    Renewal under NT-40, filed with the DRCPFA

    Official Timeline
    Min

    15

    Max

    15

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuesta

    Url

    https://www.tramites.gob.gt/servicio/3357/

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • RENOVACIONES: 15 días hábiles on trámite 3357; trámite 3358 publishes the same 15 working days for a renewal where the formula did not change.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    WHO-listed authorities of high maturity and performance (US FDA, EMA, Japan PMDA, Korea MFDS and others)

    Accepted

    No

    Benefit

    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.

  • Authority

    PAHO/PARF regional reference authorities (ARNr) and COMIECO member states

    Accepted

    No

    Benefit

    No 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.
Local Rep Required

Yes

Local Rep Name

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)

Mdsap Accepted

No

Mdsap Benefit

No MDSAP instrument was found for Guatemala. NT-37 Art. 5.1.6 accepts a GMP certificate or equivalent sanitary norm for the manufacturing laboratory, and Art. 6.12.6 names GMP, standards approval, ISO, the US FDA, the DGKC and the IFCC as acceptable manufacturing-guarantee sources.

Registration Validity

5 years from the date of grant, renewable (NT-37 Arts. 8-9; NT-40 Art. 4.3)

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: tiempo de respuesta (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Accessed Date

    2026-09-16

  • Title

    Trámite 3357 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: normativa y tiempo de respuesta

    Url

    https://www.tramites.gob.gt/servicio/3357/

    Accessed Date

    2026-09-16

  • Title

    Norma Técnica Número 37 versión 5-2016 — Inscripción Sanitaria de Dispositivos Médicos, Arts. 5, 8, 9 y Anexo 1

    Url

    https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=262:inscripcion-sanitaria-de-dispositivos-medicos

    Accessed Date

    2026-09-16

  • Title

    Norma Técnica Número 40 versión 3-2015 — Inscripción Sanitaria de Reactivos para Diagnóstico in vitro, Arts. 3 y 4.3

    Url

    https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=234:nt40

    Accessed Date

    2026-09-16

  • Title

    Norma Técnica 77 versión 8-2023 — homologation on a WHO-listed authority registration, Art. 2 (scope: chemical-synthesis medicines and vaccines only)

    Url

    https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=359:norma-tecnica-77-version-08-2023

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    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).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

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

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

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

    Duration

    20 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, MSPAS issues Guatemala market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Guatemala fees →
Jurisdiction Id

guatemala

Country

Guatemala

Country Code

GT

Authority

MSPAS

Low Risk Local
Min

100

Max

100

Currency

GTQ

Per Product

No

High Risk Local
Min

100

Max

100

Currency

GTQ

Per Product

No

Details
  • Id

    device-inscription-ia1

    Item

    Inscripción Sanitaria de Producto Afín (medical devices) — arancel item IA1

    Currency

    GTQ

    Amount Local

    100

    Amount Local Formatted

    GTQ 100

    Frequency

    Per inscription file (expediente)

    Notes

    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.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    device-inscription-renewal-ia2

    Item

    Renovación de Inscripción Sanitaria de Producto Afín — arancel item IA2

    Currency

    GTQ

    Amount Local

    100

    Amount Local Formatted

    GTQ 100

    Frequency

    Per renewal file (expediente)

    Notes

    Arancel item IA2. Trámite 3362 (renewal where no formula change occurred) publishes the same Q 100 with a 15-working-day clock.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    device-inscription-update-ia3

    Item

    Certificado de Actualización de Expediente de Inscripción Sanitaria de Producto Afín — arancel item IA3

    Currency

    GTQ

    Amount Local

    50

    Amount Local Formatted

    GTQ 50

    Frequency

    Per product updated

    Notes

    Arancel item IA3. Trámite 3363 (Solicitud de Actualización de Productos Afines) publishes Q 50 against the same item.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    ivd-inscription-ia1

    Item

    Inscripción Sanitaria de Reactivos para Diagnóstico in vitro (IVD) — arancel item IA1

    Currency

    GTQ

    Amount Local

    100

    Amount Local Formatted

    GTQ 100

    Frequency

    Per inscription file (expediente)

    Notes

    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.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    ivd-inscription-renewal

    Item

    Renovación de Inscripción Sanitaria de Reactivos para Diagnóstico in vitro — trámite 3358

    Currency

    GTQ

    Amount Local

    100

    Amount Local Formatted

    GTQ 100

    Frequency

    Per renewal file (expediente)

    Notes

    Published on the trámite record as Q 100 with a 15-working-day response time; normativa NT-40 v3-2015.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.tramites.gob.gt/servicio/3358/

    Source Title

    Trámite 3358 — Renovación de Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: costo y tiempo de respuesta

    Verified On

    2026-09-16

  • Id

    mutual-recognition-related-product-rma1

    Item

    Reconocimiento Mutuo de Producto Afín — arancel item RMA1

    Currency

    GTQ

    Amount Local

    800

    Amount Local Formatted

    GTQ 800

    Frequency

    Per recognition file (expediente)

    Notes

    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.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    advertising-authorisation-pu1

    Item

    Autorizaciones Publicitarias — arancel item PU1

    Currency

    GTQ

    Amount Local

    25

    Amount Local Formatted

    GTQ 25

    Frequency

    Per authorisation

    Notes

    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.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

  • Id

    distributor-sanitary-licence-l3

    Item

    Licencia Sanitaria de Farmacias, Droguerías y Distribuidoras — arancel item L3

    Currency

    GTQ

    Amount Local

    170

    Amount Local Formatted

    GTQ 170

    Frequency

    Per establishment licence

    Notes

    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.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Source Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Verified On

    2026-09-16

Notes
  • 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).
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Boleta de pago V-CC-G-001 versión 11-2022 (XLSX workbook, sheet DRCPFA, linked from the aranceles page) — arancel de servicios del MSPAS, issued under Acuerdo Gubernativo 53-2022 (tariff items IA1, IA2, IA3, RMA1, PU1, L3)

    Url

    https://medicamentos.mspas.gob.gt/index.php/aranceles/boleta-de-pago?download=339:boleta-de-pago-por-servicios-de-productos-farmaceuticos-y-afines

    Accessed Date

    2026-09-16

  • Title

    Trámite 3361 — Inscripción Sanitaria de dispositivos médicos: costo y tiempo de respuesta (MSPAS/MINECO national trámites record)

    Url

    https://www.tramites.gob.gt/servicio/3361/

    Accessed Date

    2026-09-16

  • Title

    Trámite 3358 — Renovación de Inscripción Sanitaria de Reactivos para Diagnóstico in vitro: costo y tiempo de respuesta

    Url

    https://www.tramites.gob.gt/servicio/3358/

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Guatemala certifications →
Slug

guatemala

Market

Guatemala

Confidence

low

Schemes
  • Id

    guatemala-medical-electrical-safety-and-emc

    Name

    Medical electrical safety and EMC evidence inside the sanitary inscription

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Guatemala operates no separate electrical-safety or EMC certificate for medical devices. The device inscription dossier is a closed thirteen-item list (NT-37 v5-2016 Art. 5.1.1-5.1.13) whose technical items are the manufacturer's original quality-control certificate and a manufacturing-guarantee certificate from a health authority naming GMP, standards approval, ISO, the US FDA, the DGKC or the IFCC; no electrical-safety or EMC test report or certificate is among them. COGUANOR technical standards, the national standards body's output, are expressly of voluntary observance, use and application under Art. 4 of the Ley del Sistema Nacional de la Calidad (Decreto 78-2005), so they impose no conformity obligation either.

    Source Urls
    • https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=262:inscripcion-sanitaria-de-dispositivos-medicos
    • https://oga.org.gt/wp-content/uploads/2021/04/Decreto-Ley-78-2005.pdf
    Source Binding

    reviewed

  • Id

    guatemala-mem-radiation-practice-and-officer-licences

    Name

    MEM radiation-practice operating licence and radiological protection officer licence

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Practice Or Use Site

    Note

    Under the Ley para el Control, Uso y Aplicación de Radioisótopos y Radiaciones Ionizantes and its Reglamento, the Ministerio de Energía y Minas (Dirección General de Energía) licenses radiation practices by type: type I at US$500 and 90 days (trámite 1408) and type II at US$200 and 90 days (trámite 1409). A separate licence is required for the Encargado de Protección Radiológica at US$50 and 30 days, and the applicant must also licence its operators and demonstrate the acquisition of a suitable detector. The obligation falls on the practice and its personnel, not on the device: a hospital cannot operate the installation without the licence even where the device carries an inscription.

    Source Urls
    • https://www.tramites.gob.gt/servicio/1408/
    • https://www.tramites.gob.gt/servicio/1409/
    • https://www.tramites.gob.gt/servicio/2456/
    Source Binding

    reviewed

Official Sources
  • Authority

    MSPAS

    Topic

    Norma Técnica Número 37 versión 5-2016 — device inscription dossier requirements

    Url

    https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/normas-tecnicas?download=262:inscripcion-sanitaria-de-dispositivos-medicos

  • Authority

    Congreso de la República de Guatemala

    Topic

    Ley del Sistema Nacional de la Calidad, Decreto 78-2005 — Art. 4 (COGUANOR standards of voluntary observance); Arts. 50-53 and 63 (CENAME legal metrology, recorded as unresolved)

    Url

    https://oga.org.gt/wp-content/uploads/2021/04/Decreto-Ley-78-2005.pdf

  • Authority

    MEM — Dirección General de Energía

    Topic

    radiation-practice operating licence, type I

    Url

    https://www.tramites.gob.gt/servicio/1408/

  • Authority

    MEM — Dirección General de Energía

    Topic

    radiation-practice operating licence, type II (medical radiodiagnosis)

    Url

    https://www.tramites.gob.gt/servicio/1409/

  • Authority

    MEM — Dirección General de Energía

    Topic

    licence for the radiological protection officer (EPR)

    Url

    https://www.tramites.gob.gt/servicio/2456/

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