Nicaragua MINSA / ANRS medical device registration under Normativa 064. Single titular required; import without registration risks product seizure. All-inclusive annual fee.
Timelines confirmed at proposal stage
Nicaragua registers medical devices through MINSA's Autoridad Nacional de Regulación Sanitaria under Normativa 064. The titular is the local importing entity; import without registration risks product seizure. bioaccess® acts as the Nicaraguan titular through our own local 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 Nicaragua.