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SINGAPORE: Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices– June/July 2023

SINGAPORE: Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices– June/July 2023

  • 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

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MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

MALAYSIA: MDA Announced the New Guidance on Harmonized Risk Classification of Medical Devices – October/November 2022

  • 2022-10-25 06:38:16

The MDA published the First Edition of the Guidance Document of the "Harmonized Classification of Medical Devices in ASEAN" (MDA/GD/0062) on September 5, 2022. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices, based on their intended use or purpose as claimed by the manufacturer.

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