The Medical Device Authority (MDA) Malaysia has released the third edition of two key guidance documents on ASEAN harmonization, one on the risk classification of medical devices, and the other on borderline product determination. These documents reflect the latest consensus of the ASEAN Medical Device Committee (AMDC) and are critical for manufacturers seeking consistency in regulatory interpretation across ASEAN Member States.
Both documents were published on 13 June 2025 and aim to support alignment with Act 737 and the Medical Device Regulation 2012 while improving regulatory predictability in the region.
Harmonized Classification of Medical Devices in ASEAN (MDA/GD/0062)
This document provides a regionally agreed list of risk classifications for various medical devices and IVDs based on their intended use as claimed by the manufacturer. The classifications have been harmonized across ASEAN through collective agreement from the 4th to the 14th ASEAN Medical Device Technical Committee (AMDTC) meetings.
Manufacturers are expected to refer to this list to determine the appropriate risk class of their products across ASEAN countries, helping reduce classification discrepancies and accelerate regulatory decision-making:
Harmonized Borderline Products in ASEAN (MDA/GD/0063)
This guidance sets out a harmonized list of borderline products, items whose status as medical devices or non-medical devices may vary depending on intended use and regulatory interpretation. The updated list includes consensus decisions made from the 5th to 14th AMDTC meetings.
These classifications help authorities and industry stakeholders distinguish between medical and non-medical products, promoting consistent market access and compliance approaches across ASEAN.
This list will be updated annually to reflect new borderline product decisions:
These guidance documents are essential for regulatory teams navigating multi-country submissions within ASEAN and are part of broader efforts to promote regulatory convergence and harmonization in Southeast Asia.
Official Sources: Third Edition MDA/GD/0062: Harmonized Classification of Medical Devices in ASEAN and Third Edition MDA/GD/0063: Harmonized Borderline Products in ASEAN
Published by MDA on 13 June 2025
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