Guideline for Classification of Medical Devices and IVDs

Guideline for Classification of Medical Devices and IVDs

This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the Authority’s current thinking on the safety, quality and performance of medical devices and IVDs. It is not intended as an exclusive approach.

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Document Number: SAHPGL-MD-04
Version: 3
Date Updated: 25/03/2023
File Type: pdf
Category: Guideline
Unit: Medical Devices