MALAYSIA : Updated in Harmonised Borderline Products in ASEAN (MDA/GD/0063) and Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) – June/July 2025

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

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MALAYSIA: Harmonised Classification of Medical Device in ASEAN –January/February 2024

• 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

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