Guatemala MSPAS / DRCPFA medical device registration under Acuerdo Gubernativo 712-99 (as updated by Acuerdo Ministerial 01-2024). Single titular with formal cession-of-rights procedure. All-inclusive annual fee.
Timelines confirmed at proposal stage
Guatemala registers medical devices through MSPAS via Acuerdo Gubernativo 712-99 (as updated by Acuerdo Ministerial 01-2024). Single titular per Certificado de Registro Sanitario; MSPAS publishes a formal cession-of-rights procedure. bioaccess® acts as the Guatemalan titular through our own local entity.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Guatemala.