Paraguay DINAVISA medical device registration under Anexo III. Único representante model — the applicant must be the single representative of the product. All-inclusive annual fee.
Timelines confirmed at proposal stage
DINAVISA's Anexo III is explicit: the applicant for a sanitary registration must be the single representative of the product. Strict single-IoR — no multi-importer shortcut. bioaccess® acts as the único representante through our own Paraguayan 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.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Paraguay.