Honduras ARSA medical device registration under Acuerdo No. 0631-ARSA-2023 (effective 28 December 2023). Local legal representative required for every registration. All-inclusive annual fee.
Timelines confirmed at proposal stage
Acuerdo No. 0631-ARSA-2023 (effective 28 December 2023) requires a local legal representative domiciled in Honduras plus a responsible technical professional at the establishment. bioaccess® acts as the Honduran representative 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.
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Related: Clinical trials in Honduras.