ISP/ANDIM market accessChile medical device registration resources
Research ISP/ANDIM registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Chile medical device resource.
Everything we track for Chile
Browse by resource instead →Additional certification and licence checker
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Chile requirements.
Medical device regulation news
Follow recent Instituto de Salud Pública de Chile — Agencia Nacional de Dispositivos Médicos (ISP/ANDIM) policy, guidance, safety, and compliance updates.
Registration timeline
Compare official and realistic ISP approval times by device class and pathway.
AI medical device classifier
Describe your device and get a preliminary ISP risk class with official rule references.
Government registration fees
Review current ISP application, review, and renewal fees.
Government fees
Full fee schedule (11 lines) →ISP/ANDIM registration fees in CLP · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| Registration dossier review (item 9100002) | CLP 487,880 | Verified |
| Registration authorization (item 9100003) | CLP 165,628 | Verified |
| Company inscription (item 9100016) | CLP 311,935 | Verified |
| Registration modification (item 9100017) | CLP 69,321 | Verified |
Registration timeline
Full registration timeline →Public Health Institute of Chile (ISP) review clocks and planning ranges · 4-class (I, II, III, IV) — D.S. 102/2014 classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| ISP sanitary registration(ISP registration) | 60 working days | 3-5 months | Verified |
- 1Pre-Submission Preparation(1-3 months)
- 2Application Submission(1-2 weeks)
- 3Administrative Review(2-4 weeks)
- 4Technical Evaluation(60 working days)
- 5Registration Approval(1-2 weeks)
Latest regulation news
All Chile regulation news →Newest ISP/ANDIM-related headlines from the daily-refreshed feed — every row links to the publishing source.
ChileAug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance GuideChileAug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?ChileAug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure SystemsChileAug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?ChileTurn Chile research into practical work
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Build a reusable product master
Structure company, product, model, approval, certificate, and evidence facts before starting Chile work.
Chile market-launch workpaper
Connect the ISP/ANDIM route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Chile dossier reuse and delta
Compare an existing authorization and evidence set against ISP/ANDIM administrative, testing, labeling, and dossier needs.
Chile change notification workpaper
Map a product or manufacturing change to ISP/ANDIM evidence, notification, timing, and implementation questions.
Chile regulatory change impact
Assess a current ISP/ANDIM update against one product and turn it into an owner-ready action workpaper.
Chile cybersecurity evidence review
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Chile (ISP/ANDIM).
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