Malaysia's Medical Device Authority (MDA) has published guidelines to help manufacturers and authorized representatives submit notifications about refurbished medical devices.
Major changes have been made to the guidance since the MDA released its draft version for a consultation back in 2020.
Refurbished Medical Device
A medical device of which the whole or any part thereof has been rebuilt, whether or not using parts from one or more used medical devices of that 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 medical device, and which may have had the following work carried out on it:
(i) stripping into component parts or subassemblies;
(ii) checking their suitability for reuse;
(iii) replacement of components/sub-assemblies not suitable for reuse;
(iv) assembly of the reclaimed and/or replacement components/sub-assemblies;
(v) testing of the assembled device against either original or revised release criteria; or
(vi) identifying an assembled medical device as a refurbished medical device.
For refurbished medical devices, the final guidance outlines two routes to market, each with its own requirements. One of the routes is for devices that are refurbished by the manufacturer.
Another option is to have devices refurbished by a third party, defined as any person authorized by a manufacturer to refurbish a medical device, and then remarket the device under its own brand name.
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