Malaysia Announces a Guidance Document for ASEAN Harmonization for some Medical Devices

In August, the Malay Medical Device Authority (MDA) issued a guidance document outlining the Association of Southeast Asian Nations (ASEAN) harmonized list of medical devices. This list includes over 250 devices and also classifies the devices (A, B, C, and D) in ASEAN. Categories of medical devices in this list include – hematology, pathology, cardiovascular, dental, ENT, gastroenterology, urology, general hospital and personal devices, and many others.

Please note that being listed as a harmonized medical device will expedite approval, but the MDA may still ask for additional information as needed for each product evaluation.