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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

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 Borderline Product in ASEAN  –January/February 2024

MALAYSIA: Harmonised Borderline Product in ASEAN –January/February 2024

  • 2024-01-26 05:18:26

The Medical Device Authority (MDA) published a second edition guidance document on “Guidance on Harmonised Borderline Product in ASEAN" on December 23, 2023. This guidance document provides a list of borderline products, whether they are medical devices or non-medical devices, based on their intended purpose as claimed by the manufacturer, which is harmonised in ASEAN. This guidance document will be updated on a yearly basis to reflect the latest decisions of the ASEAN Medical Device Committee (AMDC).

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