Saudi Arabia market access

Medical Device Marketing Authorization (MDMA)

Saudi Arabia market accessManufacturers 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.

Medical Device Marketing Authorisation (MDMA) - SFDA’s online system

The SFDA’s online system contains the regulations, guidance documents and more recently an additional guidance document (for version 1 of the MDMA database) that has been specifically developed by the SFDA in conjunction with the SFDA Designated Conformity Assessment Bodies of which there are currently five:

  • BSI
  • COSMOS
  • TUV SUD
  • TUV Rheinland
  • SGS

Version 2 of the MDMA database was released in January 2013, the latest guidance documents can be found on the SFDA website.

The guidance documents have been developed in the light of the experience already gained following the introduction of this legislation into the Kingdom as the SFDA seek to enforce and achieve the objective of ensuring a regulated market for medical devices in the Kingdom of Saudi Arabia.

This document is designed to assist you in the completion of the online MDMA Application, indicating what is required.