The ASEAN Medical Device Directive (AMDD) is an agreement established for the purpose of harmonizing medical device regulations in ASEAN countries. The ASEAN Medical Device Committee (AMDC) will update this guidance document yearly to reflect its latest decisions. The classification of medical devices is one of the requirements in the AMDD, which is stipulated in Annex 2 and 3 of Article 4 of the AMDD.
The Medical Device Authority (MDA) has announced the release of the second edition guidance document, “Guidance on Harmonised Classification of Medical Device in ASEAN," which has been available since December 12, 2023.
The revised guideline revises Annex A: List of Harmonised Classification of Medical Devices in ASEAN. There were additional medical device categories added along with devices classification and remarks in the new edition.