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Malaysia’s Medical Device Authority (MDA) has published draft guidance on medical devices that are in use but no longer registered. Products can end up in this situation when their manufacturer or authorized representative stops operating.
Such products, which MDA calls “orphaned medical devices,” pose challenges as they are in use but no longer have a representative that is responsible for them. To ensure the ongoing safe use of these devices, MDA wants healthcare facilities that use orphaned medical devices to send it a notification covering details of the product.
The notification must identify a person who is responsible for the medical device. This person must live in Malaysia and hold a top managerial position at the organization that uses the device.
MDA’s focus on the seniority of the responsible person reflects the obligations the orphaned medical device status places on healthcare facilities. In the absence of a manufacturer or typical authorized representative, the healthcare facility is responsible for the risk of using the orphaned medical device and the monitoring of its safety and performance.
The draft guidance is open for feedback until 30 November