MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN

The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations involving medical devices in ASEAN countries in August 2022. 

Annex A of the document contains all the relevant information and the medical devices’ names have been listed down, along with the class that is applicable. For example, artificial pancreas device system is included under Class C. 

Manufacturers and authorised representatives may use this document to accurately classify their medical devices, including in-vitro diagnostic (IVD) medical devices. 

More details can be found in “MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, 1st edition, August 2022”:  

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