The ASEAN Medical Device Committee (AMDC) has agreed on a definition of medical device that includes harmonised borderline goods.

The Medical Device Authority (MDA) has announced the release of the second edition guidance document, “Guidance on Harmonised Borderline Product in ASEAN”, which has been available since December 23, 2023.

The revised guideline revises Annex A: List of Harmonised Borderline Products (Medical Device or Non-Medical Device). An additional product name and description were added, along with the ASEAN decision for the device in the new edition (Addition of products from No. 181 to No. 204).



Harmonised Borderline Product in ASEAN