Guatemala MSPAS / DRCPFA device registration for FDA-cleared and CE-marked products. Single titular with formal cession-of-rights. Processing funded by you.
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. Registration ownership is not divisible. Whoever pays for the registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your MSPAS registration funded by you, the manufacturer — dossier, translations, agency liaison — while your distributor is titleholder and importer of record on paper only, with tight transfer-upon-demand clauses in your distribution agreement (reviewed by local counsel) forcing transfer to your designee on your demand. The regulator publishes a formal cession-of-rights procedure for changing the titular if the manufacturer ever wants to move the registration. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Guatemala: the titular must be the importing entity, 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 and hostage-proof contracting are quoted as a scoped engagement: dossier preparation, translations, agency liaison, and tecnovigilancia.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Guatemala.