On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows:
- MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition.
- 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 A | Addition of products from No. 181 to number No. 204 in Annex A |
Further information on these 2 (two) guidance documents can be accessed here:
- Guidance Document Harmonised Classification of Medical Device in ASEAN Second Edition (2) and
- Guidance Document Harmonised Borderline Products in ASEAN Second Edition (2)
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