Guatemala MSPAS / DRCPFA device registration for FDA-cleared and CE-marked products. Manufacturer-funded processing. Confirm the current holder rules.
Timelines confirmed at proposal stage
Guatemala registers medical devices through MSPAS via Acuerdo Gubernativo 712-99 (as amended, including by Acuerdos Gubernativos 351-2006 and 104-2018, with Norma Técnica 37). The Certificado de Registro Sanitario is issued by the Sección de Autorizaciones Sanitarias de Productos Afines and names a single titular. bioaccess® does not sell a holder subscription in Guatemala. bioaccess® can process a registration funded by the manufacturer — dossier, translations, and agency liaison — while the legal holder, the importer, and any later change of titular follow the MSPAS rules in force at filing. A distribution agreement reviewed by Guatemalan counsel can record the commercial intent. That contract does not override MSPAS and does not guarantee a transfer. Investigational use is a separate MSPAS authorization and is not granted by this commercial registration.
bioaccess® sells registration processing — not a holder subscription — in Guatemala, so there is no annual holder fee to quote. MSPAS government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required. RF homologation for wireless devices runs through Guatemala's separate telecom authority. Registration processing is quoted as a scoped engagement: dossier preparation, translations, agency liaison, and tecnovigilancia. No price or review-time guarantee is published on this page.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Guatemala.
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Regulatory sources checked November 7, 2026. General sponsor guidance, not legal advice or an approval guarantee.