Malaysia: MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN

On September 5^th 2022, the MDA released two First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062) and the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063).

These guidance documents are mostly concerned with:

1. Harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer as listed in Annex A of First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062).
2. The list of borderline products whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer which is harmonized in ASEAN Annex A of the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063).

For further information on the released two First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062) and the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063).

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