Malaysia drafts new regulations on “orphaned” medical devices

Healthcare facilities in Malaysia would be required to notify government authorities if they employ medical devices whose registration has lapsed, under a new guidance drafted by the country’s Medical Device Authority. The use of such “orphan” devices has been a recurring issue in Malaysia, where medical devices are often kept in use even after their manufacturers have ceased operations in the country. That poses risks for medical professionals in ensuring the safety and performance of the device. Under the draft guidance, facilities using such devices would be required to designate a staff member responsible for the smooth operation and maintenance of them.