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Malaysia: MDA Issued Two Updated Guidance Documents on Harmonised Classification and Borderline Products in ASEAN 

On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows:

  1. MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition.
  2. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition.

These are the highlights of each regulation:

Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062)Harmonised Borderline Products in ASEAN 2nd Edition (MDA/GD/0063)
Addition of Medical Devices as listed in Annex AAddition of products from No. 181 to number No. 204 in Annex A

Further information on these 2 (two) guidance documents can be accessed here:

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