Nicaragua MINSA / ANRS device registration under NTON 24001:2023: the product owner holds the registro and authorizes local distributors. Funded by you.
Timelines confirmed at proposal stage
Nicaragua registers medical devices through MINSA's Autoridad Nacional de Regulación Sanitaria under NTON 24001:2023, which repealed Normativa 064. Under the norm, the titular of the sanitary registration is the entity that grants distribution, registration and/or legal-representation authorizations to the person or company it designates in Nicaragua, so the product owner holds the registration and its distributor acts under an ANRS-approved power or distribution letter. NTON 24001 also provides a post-registration route to change or add a distributor. bioaccess® processes your MINSA registration funded by you, the product owner (dossier, translations, agency liaison), with you as titular and your distributor authorized under NTON 24001. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Nicaragua: the product owner is the titular under NTON 24001:2023, so there is no annual holder fee to quote. MINSA 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 Nicaragua's separate telecom authority. Registration processing is 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 Nicaragua.