New compliance rules

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

On September 5th 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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