Chile medical device registration timeline
Source-linked clocksPublic Health Institute of Chile (ISP/ANDIM) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) — D.S. 102/2014 classification system.
2 pathways2 of 2 clocks verifiedvalidity 3 years under Código Sanitario art. 7, automatically and successively extended for equal periods unless expressly revokedMDSAP acceptedreviewed 2026-08-30ispch.cl
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| ISP sanitary registration (medical devices)(ISP registration) ISP ficha 9100003 v03: 60 working days on average, provided no new documents are requested; the clock is a service-charter average rather than a statutory maximum | 60 working days | 3-5 months | — | Verified |
| ISP sanitary registration (in vitro diagnostics)(ISP registration) ISP ficha 9100019 v08: 60 working days on average counted from the date evaluation starts, provided no new documents are requested | 60 working days | 3-5 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Chile Medical Device Registration Process
Step-by-step ISP/ANDIM registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by ISP/ANDIM. Appoint a Chilean Legal Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ISP/ANDIM including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksISP/ANDIM reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
60 working daysIn-depth technical assessment of device safety and performance. ISP/ANDIM may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ISP/ANDIM issues Chile market authorization certificate.
Summary: The Chile medical device registration process through Public Health Institute of Chile (ISP/ANDIM) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
CE Mark (EU MDR)Chile requires ISP registration only for the controlled device families; for everything else the certificate supports importation rather than a registration decision. Where registration does apply, the ISP period does not vary with origin.None published
FDA 510(k)/PMAAccepted as evidence of conformity alongside the certificate of free sale, with no published reduction.None published
Key requirements
- Registration is category-scoped rather than universal: only the products a decree has placed under sanitary control need an ISP registration, currently latex surgical and examination gloves, latex and synthetic male condoms, female condoms, sterile single-use hypodermic needles and syringes, portable AEDs, HIV self-tests and professional HIV assays, and immunohaematology reagents
- Decreto Exento 25/2026 adds a further 39 device and IVD categories to that list, phased in from 2028, so products outside the current list should plan for a registration clock they do not yet face
- Three prerequisites gate the registration file and carry their own published clocks: company inscription (ficha 9100016, 25 working days, indefinite validity), warehouse authorisation (ficha 9200007, 45 working days in the Región Metropolitana and 60 working days elsewhere, 5-year validity), and the customs-destination certificate (CDA) obtained through GICONA
- Local Authorized Representative (Chilean legal representative) holding the registration on the foreign manufacturer's behalf under a written mandate
- Free-sale certificate, ISO 13485 evidence and manufacturer designation letters must be consularised or apostilled
- Changes that alter design, material chemistry, principal component, biocompatibility, energy source or manufacturing process are treated as a new registration rather than a modification
MDSAP: Accepted as QMS evidence
Primary regulator sources
ispch.cl · ISP Chile ficha 9100003 v03 (25-09-2025) — registro sanitario de dispositivos médicos: 60 días hábiles en promedio, vigencia 3 años ispch.cl · ISP Chile ficha 9100019 v08 (01-07-2026) — registro sanitario de DMDIV: 60 días hábiles en promedio desde el inicio de la evaluación ispch.cl · ISP Chile ficha 9100016 v02 (28-08-2024) — inscripción de empresa: 25 días hábiles en promedio, vigencia indefinida ispch.cl · ISP Chile ficha 9200007 v2 (21-07-2025) — autorización de bodega: 45 días hábiles Región Metropolitana, 60 días hábiles regiones ispch.cl · ISP Chile ANDIM — registro sanitario de DM y DMDIV: lista de categorías bajo registro obligatorio por decreto
Reviewed 2026-08-30. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against ISP/ANDIM publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:chile:isp-registration