MDA Malaysia Publishes Guidance Document on Refurbished Medical Devices

The Malaysian Medical Device Authority (MDA) has published a guidance document on the requirements for refurbished medical devices in January 2022. 

The guidance will be able to assist manufacturers and authorised representatives (AR) in the registration process of these refurbished medical devices. 

Some main points mentioned are that refurbishment activities must adhere to the requirements of the Good Refurbishment Practice for Medical Devices (GRPMD) and that the labelling of the medical device must include the term “Refurbished”. A different catalogue number with a suffix of [R] must also be used. 

More details can be found in “MDA/GD/0060 Refurbished Medical Device – Requirements, 1st edition, January 2022”:  

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