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ISP/ANDIM ISP

ISP Risk Classification Guide (General Devices)

Guide for Risk Classification of Medical Devices
ChileInstituto de Salud Pública de ChileClassification
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What this code is

ISP Risk Classification Guide (General Devices) is the official ISP / ANDIM identifier for “Guide for Risk Classification of Medical Devices”. ISP Risk Classification Guide (General Devices) is the official identifier ISP / ANDIM uses for this instrument.

Instrument
ISP
Full name
ISP Risk Classification Guide (General Devices)
Category
Classification
Source links
Authority source
Spanish
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Dates
Published
June 2018
Effective
—
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Spanish full text0 articles · Spanish — official ISP general-device classification guideRead HTML →
About this regulation

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.

ISP Risk Classification Guide (General Devices) is the official identifier ISP / ANDIM uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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