Chile ISP medical device registration for FDA-cleared and CE-marked products. Currently voluntary registration; imports allowed via CDA permit. 30–90 day published timeline, single all-inclusive annual fee.
30–90 days
Chile ISP registration is currently voluntary; any entity can import a medical device via a CDA permit. bioaccess® still holds and manages Chilean registrations through our own local entity for regional consistency.
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 Chile.