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Guatemala medical device regulations

Official sources linked

MSPAS rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

3 documents2 categories100% linked to official sourcesauthority MSPAS3 readable HTML
CodeRegulationCategoryEffectiveProvenance
Acuerdo Gubernativo 712-99
Reglamento para el Control Sanitario de los Medicamentos y Productos Afines
Acuerdo Gubernativo Número 712-99, Guatemala, 17 de septiembre de 1999, signed by the Presidente de la República (the signature block prints "ALVARO ARZU") and the ministers concerned: the Reglamento para el Control Sanitario de los Medicamentos y Productos Afines, which is Guatemala's operative control instrument and the one under which medical devices are regulated as productos afines. Seven títulos and 109 articles. Título II is the substantive core for a device applicant — classification, the registro sanitario de referencia, plaguicidas de uso doméstico, the productos afines subject to control, and imports and exports; Título III covers estupefacientes, psicotrópicos y precursores; Título IV the establishments; Título V farmacovigilancia; Título VI the rational use, dispensing and advertising of medicines; Título VII the final and transitional provisions. Article 109 brings it into force eight days after publication in the diario oficial; the document states no publication date of its own, so none is recorded. Twenty-two of the 109 article lines print their title wrapped onto the next line mid-phrase (article 13 ends "…DE REFERENCIA E"), so those articles carry no heading rather than a truncated one; the article text itself is complete. Título V prints no title of its own — the source runs "TITULO V" straight into "CAPITULO UNICO" and the título's subject appears only as the chapter title FARMACOVIGILANCIA — so the block structure follows the page as printed.
General—Official
Acuerdo 506-2002 / Resolución 93-2002 (COMIECO-XXIV)
Acuerdo No. 506-2002 que publica la Resolución No. 93-2002 (COMIECO-XXIV) — Reconocimiento de Registros Sanitarios de Medicamentos y Formato Único de Certificado de Producto Farmacéutico
Acuerdo No. 506-2002 of the Ministerio de Economía (Guatemala, 31 de octubre de 2002, signed by Ministra Patricia Ramírez Ceberg), which publishes the COMIECO resolution Resolución No. 93-2002 (COMIECO-XXIV) — the Central American mutual recognition of medicine sanitary registrations, the single format for the Certificado de Producto Farmacéutico, and, in its ANEXO 3, the Reglamento de Buenas Prácticas de Manufactura de la Industria Farmacéutica (243 articles across eleven títulos). Eight annexes in all: the mutual recognition procedure, the certificate format, the GMP reglamento, the list of pharmacopoeias and scientific literature, the alphanumeric coding for sanitary registrations, the sampling requirements, the GMP inspection and self-inspection guide, and the grounds for cancelling a recognised registration. Two things a reader must not miss. First, the resolution's own numeral 3 states that it "no es aplicable ni surte efectos en Costa Rica y Guatemala" — Guatemala publishes the regional instrument without applying it territorially, so this row is evidence of the regional framework and not of a Guatemalan approval route; the operative Guatemalan route is AG 712-99. Second, ANEXO 3 misnumbers its ninth título as "TITULO IV" (TÍTULO IV appears twice and TÍTULO IX never appears), so the block ids follow the título's position while the label keeps the numeral the source prints.
Registration—Official
Cuadro Resumen — Pago de Aranceles (DRCPFA y LNS)
Cuadro Resumen — Pago de Aranceles en el Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA) y Laboratorio Nacional de Salud (LNS)
The DRCPFA's summary of what an applicant pays and to whom, covering both the DRCPFA and the Laboratorio Nacional de Salud: products farmacéuticos (including the registration, recognition and renewal lines) and productos afines (inscripción sanitaria, reactivos de diagnóstico, cosméticos, médico quirúrgicos, higiénicos and odontológicos), each row giving the folder colour, whether the DRCPFA and LNS fees apply, and whether an expediente must be delivered to the LNS. A Nota explains the renewal-with-formulation-change case, and an Información Importante section sets out the receipt 63 A2 rules, including the three-month validity of a DRCPFA receipt and the reference to Acuerdo Gubernativo 53-2022. It is an administrative notice rather than a legal instrument, and it states no publication date; the dates it does carry are the operational cut-offs it cites (1 April 2022 and the Comunicado references). The tables are exposed as sections and their cell contents preserved as the PDF lays them out.
General—Official
Exports carry source + retrieval date

Changes after registration in Guatemala

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval
  • Supporting documents

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

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.'

Change control →Economic-operator roles →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Change control →Economic-operator roles →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Change control →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

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Compare existing evidence against Guatemala needs.

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Assess a regulatory change

Test a current MSPAS update against one product and its evidence.

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Tracked from official MSPAS publications · row IDs are stable — cite as regulations:guatemala:ag-712-99