Saudi Arabia Changes Policies for Imported Devices, IVDs
Saudi Arabia’s Food and Drug Authority eased import requirements for lower-risk devices in a move expected to reduce the time devices and IVDs may be held at ports.
The authority issued new guidance noting that lower-risk medical devices that are non-sterile no longer require formal registration.
The new requirements address labeling, shelf life and temperature requirements as well as general requirements for registering devices and IVDs in Saudi Arabia. The guidance says shipments that meet certain criteria relating to the importers’ past compliance history may be cleared faster and without inspection.