Malaysia Issues Guidance on Refurbished Medical Devices

Malaysia’s Medical Device Authority has clarified its definitions for refurbished medical devices and offered guidance for devicemakers submitting notifications for such products.

The MDA said that a medical device is considered refurbished when any part has been substantially rebuilt, whether or not parts used are from one or more used medical devices of the same kind, “so as to create a medical device that can be used for the purpose originally intended by the product owner of the original device.”

The refurbished device may have been stripped into component parts of sub-assemblies, checked for suitability for reuse or had components replaced that weren’t suitable for reuse.