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    ISP / ANID

    Flag of ChileChile - ISP / ANID

    EmergingLast updated · Mar 2026 (MINSAL Exempt Decree No. 25 published Mar 19 2026; expands medical device & IVD oversight under the Public Health Code)Verified · 2026-07-16

    Decreto 825 framework + new Medical Device Law (Ley 21.541)

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    Authority

    Instituto de Salud Pública de Chile

    Enforced

    2024 (Ley 21.541 in implementation); Exempt Decree No. 25/2026 published Mar 19 2026

    Legal framework

    Ley 21.541 (2023) + ISP regulations + Ley 19.628 data protection

    FDA package reuse

    ~80%

    Scope

    Medical devices marketed in Chile; risk-class based registration phasing in under Ley 21.541.

    Pre-market

    Reference-jurisdiction route during transition; risk-based dossier expected once implementing decrees publish.

    Post-market

    Tecnovigilancia reporting via ISP; CSIRT.gob.cl coordination for incidents.

    SBOM

    Recommended

    Encouraged via FDA / EU alignment.

    Vulnerability disclosure

    CSIRT.gob.cl coordinated disclosure recommended.

    Penalty

    Registration suspension, sanitary fines under Health Code.

    Unique requirements

    • 01Chilean Registration Holder
    • 02Spanish-language IFU and labelling
    • 03ISP authorisation for importers

    Highlights

    • New MD Law transitioning into force
    • Reference jurisdiction route during transition
    • Modernised data-protection law incoming

    Aligns with

    IMDRF N60 ISO 13485 FDA 2023 Guidance

    Timeline

    1. Mar 2023

      Ley 21.541 enacted

    2. 2024

      Implementing regulations under consultation

    3. Mar 19 2026

      MINSAL publishes Exempt Decree No. 25 incorporating medical devices & IVDs into the Public Health Code

    Key documents

    How to submit in Chile

    Playbook reviewed · 2026-07-16

    Submission route

    ISP notification / registration

    Chile operates a light-touch notification regime for most devices, with registration required for higher-risk categories.

    Authority portal

    Step-by-step

    1. Step 01

      Appoint local representation

      Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.

    2. Step 02

      Reuse FDA or CE package as baseline

      Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.

    3. Step 03

      Translate and localise

      Local-language technical summary and labeling are usually mandatory; certified translation is safest.

    4. Step 04

      Submit + track queries

      Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.

    Evidence checklist

    Item Level FDA equivalent Notes
    Cybersecurity documentation (baseline FDA or CE) Required SPDF
    Local authorised representative agreement Required —
    Local-language labeling and IFU Required —
    SBOM Recommended — Not mandatory but reduces clarification rounds.

    Common ISP rejections

    Reference approval documentation missing

    Occasional

    Fix · Attach FDA/CE evidence to shortcut the review.

    Typical timeline

    End-to-end window: 2-6 months

    Phase 01

    Local rep + dossier prep

    2-4 months

    Phase 02

    Regulatory review

    2-6 months

    Phase 03

    Approval + market entry

    1-3 months

    Frequently asked about Chile

    Is SBOM required for medical devices in Chile?

    Recommended. Encouraged via FDA / EU alignment.

    What does ISP / ANID require for pre-market cybersecurity?

    Reference-jurisdiction route during transition; risk-based dossier expected once implementing decrees publish.

    What are the post-market cybersecurity obligations under ISP / ANID?

    Tecnovigilancia reporting via ISP; CSIRT.gob.cl coordination for incidents.

    What is the penalty for non-compliance with ISP / ANID cybersecurity rules?

    Registration suspension, sanitary fines under Health Code.

    How much of my FDA cybersecurity package is reusable in Chile?

    Roughly 80% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).