Paraguay DINAVISA medical device registration under Anexo III. Strict único representante — applicant is the single representative. 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.
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 Paraguay.