Malaysia signed the Agreement of the ASEAN Medical Device Directive (AMDD) in April 2020. The purpose of this agreement is to stabilize medical device regulations across ASEAN countries, offering stakeholders guidance on the risk classifications of general and in-vitro diagnostic (IVD) medical devices based on their claimed intended use.

To reflect the latest decisions of the ASEAN Medical Device Committee (AMDC), the documentation will be updated annually.

Harmonized Risk Classifications

The MDA has listed the harmonized risk classifications in Annex A, which is divided into several categories of devices:

1. Clinical Chemistry and Clinical Toxicology
2. Immunology and Microbiology
3. Cardiovascular
4. Dental
5. Ear, Nose, and Throat
6. Clinical Chemistry and Clinical Toxicology
7. Gastroenterology-Urology
8. General and Plastic Surgery
9. General Hospital and Personal Use
10. Neurological
11. Obstetrical and Gynecological
12. Physical Medicine
13. Radiology
14. Hematology and Pathology

For more information about the First Edition of the Harmonized Classification of Medical Devices in the ASEAN Guidance Document, please visit MDA/GD/O062.

Reference:
ASEAN Guidance Document on Harmonized Classification of Medical Devices - https://www.mda.gov.my/documents/guidance-documents/2194-guidance-document-harmonised-classification-of-medical-device/file.html