Saudi FDA Allows “Compassionate Use” Program for Some Medical Devices

EMERGO SUMMARY OF KEY POINTS

• The Saudi Food and Drug Authority has implemented a process for importing medical devices into the country to address national emergency situations.
• Manufacturers must meet importation licensing and shipping clearance documentation requirements under the new program.

The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has issued new guidance on how foreign manufacturers should obtain importation licenses and shipping clearance for devices needed in “national emergency situations.”

In general, the SFDA requires devices to have obtained medical devices importation licenses (MDIL) from the SFDA prior to their use in national emergency situations; to obtain an MDIL, a firm must submit documentation such as an MDIL application form, healthcare provider attestation, copy of a valid Medical Devices Establishment License (MDEL) and Declaration of Conformity (DOC).

The guidance also lists required documents for obtaining shipping clearance at Saudi ports of entry: copies of an MDIL and MDEL, original purchase invoice and original certificate of origin.

Implementation of this new program for devices during emergency situations was previously absent from the Saudi Arabian medical device regulatory system.

Additional information on medical device registration in Saudi Arabia can be found by reading our whitepaper or downloading our regulatory process chart.