Bolivia AGEMED medical device registration under the Manual para Registro Sanitario (T-N-11-RM-0909). Single registered local entity. Processing funded by you.
Timelines confirmed at proposal stage
Bolivia's AGEMED, under the Ministerio de Salud, issues sanitary registration for medical devices to a single registered local entity per device, in accordance with AGEMED's Manual para Registro Sanitario T-N-11-RM-0909 and current resolutions. 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 AGEMED 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. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Bolivia: the holder must be the importing entity, so there is no annual holder fee to quote. AGEMED 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 Bolivia'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 Bolivia.