Chile medical device regulations
Official sources linkedISP/ANDIM rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| ISP Risk Classification Guide (General Devices) | Guide for Risk Classification of Medical Devices Official 28-page ISP guide for Classes I-IV, application criteria, rules, and concrete examples. ISP still lists the guide in its current technical-guidance collection (https://www.ispch.cl/andim/guias-tecnicas-y-material-de-capacitacion/); it is guidance evidence, not a product-type catalogue or a substitute for the controlling legislation. | Classification | — | Official |
| ISP Risk Classification Guide (IVD) | Guide for Risk Classification of In Vitro Diagnostic Medical Devices Official 18-page ISP guide for IVD risk classes, seven rules, application criteria, worked examples, and decision diagrams. ISP still lists it in the current technical-guidance collection (https://www.ispch.cl/andim/guias-tecnicas-y-material-de-capacitacion/); it is guidance evidence rather than a generic product catalogue. | Classification | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
Keep Chile as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for Chile
Check a preliminary ISP/ANDIM risk class.
Compare products across markets
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Build a registration plan
Estimate pathway, government fees, preparation, and review time.
Build a reusable product master
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Map dossier reuse and deltas
Compare existing evidence against Chile needs.
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Assess a regulatory change
Test a current ISP/ANDIM update against one product and its evidence.