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MALAYSIA: MDA/GD/0005 about General Medical Device Grouping - February/March 2024

MALAYSIA: MDA/GD/0005 about General Medical Device Grouping - February/March 2024

  • 2024-03-01 07:14:04

The Medical Device Authority (MDA) published the Second edition Guidance Document, "Guidance on General Medical Device", on January 30, 2024. This guidance document provides aims to help determine the appropriate grouping for medical devices in the medical device registration application. This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.

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SINGAPORE: HSA Introduced Medical Device Grouping Tool

SINGAPORE: HSA Introduced Medical Device Grouping Tool

  • 2021-04-26 02:04:12

Health Sciences Authority (HSA) introduced a new self – help tool for grouping of medical devices prior to registration. This new tool will aid in the reduction of the number of applications and will in turn reduce the cost and is applicable to different product types.

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