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.
Mexico Updates Electronic Advertising Recommendations
Mexico’s Federal Commission for Protection Against Sanitary Risks (COFEPRIS) has revised some of its guidelines for advertising medical devices via social media.
Device manufacturers should submit proposed advertising to the agency before it is launched online. The regulatory authority recommended that companies designate digital experts to help manage in-house and third-party content.
Earlier this year, COFEPRIS announced it would deregulate many of its lower-risk devices, enabling earlier market access. The move also allows the regulator to focus on enabling earlier access for innovative devices (IDDM, Feb. 23).