Chile ISP medical device registration for FDA-cleared and CE-marked products. Required for specified categories; CDA permit otherwise. Processing funded by you.
30–90 days
Chile's regime is transitional: ISP registration is currently mandatory only for specified device categories and voluntary for others, with Exempt Decree No. 25 (2026) adding 39 listed device types by 19 March 2029 and registration of all device classes by risk still only a bill (Boletín 17.375-11). For devices not yet in a mandatory category, any entity can import via a CDA permit. Registration ownership is not divisible. Whoever pays for the registration controls it: a distributor that funds the filing will hold it hostage and refuse transfer. bioaccess® processes your ISP registration funded by you, the manufacturer — dossier, translations, agency liaison — while your distributor is titleholder and importer of record on paper only, with tight transfer-upon-demand clauses in your distribution agreement (reviewed by local counsel) forcing transfer to your designee on your demand. See the LATAM Importer of Record guide for the full country breakdown.
bioaccess® sells registration processing — not a holder subscription — in Chile: the titleholder must also be the importer, so there is no annual holder fee to quote. ISP government submission fees are set by the regulator; certified Spanish translation of IFU, labels, and technical file is typically required. Chile SUBTEL RF homologation for wireless devices runs through a separate authority. Registration processing and hostage-proof contracting are 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 Chile.