Singapore’s Health Sciences Authority has updated its guidance on how manufacturers should notify the agency of modifications to registered medical devices.
The new Guidance on Change Notification for Registered Medical Devices contains several revisions, all of which took effect Dec. 1.
When changes arise from adverse events or field safety corrective actions, devicemakers now should submit information — such as field safety notices, health hazard evaluations, root cause analysis and corrective and preventive actions, the guidance says.
Upon approval of a change notification application, devicemakers may now concurrently supply both the original registered device along with the changed device only if both versions conform to the Essential Requirements for Safety and Performance, the document says.
“This concurrent supply of the unchanged original device may not be applicable for changes to medical devices implemented as a consequence of reportable AEs or FSCAs,” the HSA says.
In addition, the new guidance says that adding devices with proprietary names that are different from the registered product in a listing will not qualify for change notification. Instead, they require submission of a new premarket registration.
Also, adding new models to a registered device listing now requires HSA approval prior to implementing the changes.