Decree 25/2026
Published 19 March 2026: ISP becomes the conformity body, 24 months for high-risk implantables, 36 months for the rest — with voluntary early compliance.
Free field guide · PDF
Chile ISP Medical Device Registration2026 Field Guide
The March 2026 Decree 25/2026 reset, the 24/36-month implementation ladder, and the ISP conformity route — with the classic registration picture.
- 24-month deadline
- Mar 2028
- 36-month deadline
- Mar 2029
- Classic route
- 75 WDs
Sourced from Decree 25/2026 sources and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Decree 25/2026 sources and verified 2026 publications.
The ISP-ANAMED route
Form ANDID-001 via an IOR: ~75 working days, ~$350 filing fee, Class I–IV dossier — FSC, QMS certs, Spanish labels, IFU.
Why Chile still matters
Stringent-jurisdiction approvals can streamline review, Spanish labeling is essential, and enforcement has tightened.
Sources & scope
- carey.cl, MINSAL incorporates new medical devices into sanitary control regime (Mar 2026).
- scrconsultores.com.pe, medical device health registration in Chile: Decree 25/2026.
- indexbox.io, Chile sterile surgical or dental adhesion barriers market report 2026.
- meddeviceonline.com, medtech in Chile: current Latin America's easiest market.
This guide is market-access intelligence, not regulatory or legal advice. Decree 25/2026 implementation, ISP timelines, and classification practice change — professional review is required before business use.
Market Access Strategy Session
Chile on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your ISP route — Decree 25/2026 sequencing, IOR setup, and dossier planning.
Professional review is required before business use.
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