Paraguay DINAVISA registration under Resolución 226/2024: the importer named in the manufacturer's letter applies; an exclusive letter wins. Funded by you.
Timelines confirmed at proposal stage
Under DINAVISA Resolución 226/2024, Art. 6(b), an imported device is registered by the importing company named in the manufacturer's power of representation or distribution and marketing authorization letter. If two or more companies present themselves as representatives of the same manufacturer, DINAVISA registers the device to the company holding an exclusive representation letter; if there is no exclusivity clause, to the company holding a letter issued directly by the manufacturer, setting aside companies whose letters were issued by distributors. Sponsors that need broad Paraguayan distribution should plan around the single-IoR rule rather than against it. 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 DINAVISA 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.
Source: DINAVISA Resolución 226/2024, Art. 6(b) (requisitos, producto importado)
bioaccess® sells registration processing — not a holder subscription — in Paraguay: the applicant is the importing company named in the manufacturer's letter (Resolución 226/2024, Art. 6(b)), so there is no annual holder fee to quote. DINAVISA 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 Paraguay'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 Paraguay.