ISP/ANDIM · structured requirements

🇨🇱 Chile medical device regulatory data

Explore the medical device requirements currently available for Chile, organized by topic and linked to official sources.

2 facts2 dimensions2 official sourceslatest verification 2026-08-13

Authority & regime

Which authority and binding regime govern this product, task, and date?

authority.competent-authority

Instituto de Salud Pública de Chile — Agencia Nacional de Dispositivos Médicos (ISP/ANDIM)

Which registration, notification, listing, reliance, or conformity route applies?

registration.market-access-route

SubmissionSurface: GICONA online system for covered products; defined exceptions use in-person filing
VerifiedHighlights: The official page maintains the current device categories subject to mandatory sanitary registration.
A significant change can require a new registration; non-significant changes may be modified within the existing registration.

Need to apply Chile's requirements to a product?

Confirm the current ISP/ANDIM pathway, evidence, and local-role details for the actual device before filing.