On 23 April 2020, Malaysia signed the agreement on the ASEAN Medical Device Directive (AMDD) to harmonize the medical device regulations in the ASEAN countries. The guidance intends to guide the stakeholder on the harmonized list of risk classification of general and in-vitro diagnostic (IVD) medical devices based on the claimed intended use or purpose. To reflect the latest decisions of the ASEAN Medical Device Committee (AMDC), MDA/GD/0062 will be updated yearly.

MDA has listed the harmonized risk classification in Annex A and divided it into several category devices as stated below:

1. 1. Clinical Chemistry and Clinical Toxicology
2. 2. Immunology and Microbiology
3. 3. Cardiovascular
4. 4. Dental
5. 5. Ear, Nose, and Throat
6. 6. Clinical Chemistry and Clinical Toxicology
7. 7. Gastroenterology-urology
8. 8. General And Plastic Surgery
9. 9. General Hospital and Personal Use
10. 10. Neurological
11. 11. Obstetrical and Gynecological
12. 12. Physical Medicine
13. 13. Radiology
14. 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/0062.

 

 

References:
Harmonized Classification of Medical Devices in ASEAN