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ISP/ANDIM ISP

ISP Risk Classification Guide (IVD)

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

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

Instrument
ISP
Full name
ISP Risk Classification Guide (IVD)
Category
Classification
Source links
Authority source
Spanish
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Dates
Published
April 2019
Effective
—
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Spanish full text0 articles · Spanish — official ISP IVD classification guideRead HTML →
About this regulation

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.

ISP Risk Classification Guide (IVD) 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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