Chile ISP medical device registration for FDA-cleared and CE-marked products. Registration is currently mandatory only for specified device categories and voluntary for others; a 2024 reform is progressively extending it to all classes. Imports of non-mandatory devices allowed via CDA permit. Single all-inclusive annual fee.
30–90 days
Chile ISP registration is currently mandatory only for specified device categories and voluntary for other devices; a 2024 reform is progressively extending mandatory registration to all device classes by risk. Devices not yet in a mandatory category can be imported via a CDA permit. bioaccess® still holds and manages Chilean registrations through our own local entity for regional consistency.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
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.