Malaysia Issues Guidance on Refurbished Medical Devices
Malaysia’s Medical Device Authority 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 had the following work carried out:
- Stripping into component parts;
- Checking their suitability for reuse;
- Replacing components/sub-assemblies not suitable for reuse;
- Assembly of the reclaimed and/or replacement components or sub-assemblies;
- Testing of the assembled device against either original or revised release criteria; or
- Identifying an assembled medical device as a refurbished device.