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.
First device family low-to-mid risk USD 7,500/yr, all-inclusive. Additional families +USD 3,500/yr.
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.
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Related: Clinical trials in Guatemala.