The Malaysian Medical Device Authority (MDA) has released the second edition of the guidance document on the rules of classification for general medical devices in May 2022.
There are updates to the terms and definitions for some terms such as cleaning, radiopharmaceuticals, and surgically invasive medical devices.
As for the classification of medical devices, if there is any dispute between an establishment and conformity assessment body, the establishment can write to MDA within 30 days from the date of dispute. MDA will provide the final decision on the suitable classification.
More details can be found in “MDA/GD/0009 Guidance on the Rules of Classification for General Medical Devices, 2nd edition, April 2022”: https://www.mda.gov.my/documents/guidance-documents/1978-mda-gd0009-classification-of-general-medical-device/file.html