Malaysian Regulator Asks for Comments on Orphaned Devices

Malaysia’s Medical Device Authority is asking for industry input on a proposal to allow the continued use of  orphaned devices that can’t be registered because the manufacturer or authorized representative in Malaysia is no longer available.

Numerous such devices were in use in hospitals before Malaysia enacted a new medical device law in 2018. The act made it illegal to sell devices without a license, which means that many devices would need to be withdrawn from the supply chain.

The agency is proposing that the devices continue to be used, and that healthcare facilities with orphaned devices identify them and provide notification.