Guatemala medical device regulations

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.

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.

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.