Gain market access in Saudi Arabia with MDMA approval

Medical Device Marketing Authorization (MDMA)

Saudi-Arabia-flagManufacturers wishing to place goods in the Saudi market must now provide the Saudi Food & Drug Authority (SFDA) with documentation that demonstrates that the device is authorized to be placed on the market.

The SFDA recently introduced the Medical Devices Interim Regulation (MDIR), part of which is the Medical Device Marketing Authorization (MDMA) system which mandates the granting of a Market Authorization License for all Medical Devices imported into the Kingdom.