Guatemala MSPAS / DRCPFA medical device registration for FDA-cleared and CE-marked products. Single titular with formal cession-of-rights. 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.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
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.