The Medical Device Authority (MDA) has issued the Third Edition of the Guidance Document MDA/GD/0062: Harmonised Classification of Medical Devices in ASEAN. This document supersedes previous editions and provides an updated list of harmonised risk classifications for general and in-vitro diagnostic (IVD) medical devices, as agreed by the ASEAN Medical Device Committee (AMDC).
The classification system remains aligned with the risk-based approach under the ASEAN Medical Device Directive (AMDD), categorizing devices into Classes A, B, C, and D based on intended use, invasiveness, duration of contact, and other relevant factors.
Access the Guidance Document:
Third Edition of MDA/GD/0062 – Harmonised Classification of Medical Devices in ASEAN
Key Highlights
Expanded Annex A
- Incorporates updated device classifications from the 4th to 14th AMDC Technical Committee meetings (AMDTC).
New Devices Added
- Many new device types and classification scenarios added, including specific notes based on use conditions.
IVD-Specific Updates
- Additional IVD categories included, with greater emphasis on transmissible agents and public health impact.
Annual Review Practice Confirmed
- Confirms that the guidance will be reviewed annually to reflect AMDC decisions and maintain regional harmonisation.
Important Notes
- All establishments are required to review the current classifications of their medical devices to ensure compliance with the updated Annex A.
- The updated classification framework may affect product registration pathways, particularly where a device has been reclassified to a higher risk class.
- Failure to apply the correct classification may result in application rejections, processing delays, or non-compliance findings during regulatory audits.
Revision History
- Initial Release: 5 September 2022
- Rev 2: 12 December 2023
- Updated classification list based on 4th–10th AMDC Technical Committee (AMDTC) decisions.
- Rev 3 (Current): 13 June 2025
- Expanded Annex A to include classifications from 11th–14th AMDTC
- Refined classification notes, exceptions, and device-specific conditions
- Document restructured to support annual review and harmonisation across ASEAN
Implications to Clients
Clients are advised to review the updated classification list to determine any changes affecting their products and ensure that all related documentation and registration plans are updated accordingly.
Failure to comply may result in registration rejection, regulatory non-compliance, or delays in market approval.
Effectivity
The updated guidance is effective from 13 June 2025.
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