Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on documents for Refurbished Medical Device. This new guidance document specifies requirements for refurbished medical devices to be place in the Malaysian market.
The registration of Refurbishment medical devices can be conducted by manufacturers and third party refurbishers. A third-party refurbisher is someone who has been authorised by the manufacturer to refurbish a medical device. If a third-party refurbisher sells a refurbished medical item under his own name, he is considered a manufacturer. There are two routes for the registration, which are Route A and Route B. The term "Refurbished" must be included on the medical device label, as well as a different catalogue number with the suffix [R].
Registration applications must be completed and submitted through the MeDC@St system in accordance with the requirements for registration.
Guidance Document Refurbished Medical Device - Requirements