Saudi Arabia Medical Device Interim Regulations Update

The recently introduced Medical Device Interim Regulations has made Saudi Arabia a regulated market for all types of medical devices.  All manufacturers wishing to supply a Medical Device within Saudi Arabia now require Saudi Food & Drug Authority (SFDA) Market Authorisation.  Manufacturers wishing to place goods in the Saudi market must now provide the SFDA with documentation that demonstrates that the device is authorised to be placed on the market in one of the GHTF Founding Member jurisdictions (Australia, Canada, Europe, Japan or USA) and that it complies with the specific Saudi requirements specified in the Medical Device Interim Regulation (MDIR). SFDA will issue a marketing authorisation in writing to the manufacturer, when it is satisfied that the relevant requirements have been met.

It is therefore important for any manufacturer wishing to place goods on the Saudi market to engage with the process in place at the SFDA without delay, since it is likely that failure to either have approval or actually in process of approval could result in products being prevented from either entering the country, being sold or used.

SFDA Medical Device Interim Regulation (MDIR)

The SFDA Medical Device Interim Regulations can be found on the SFDA website.
www.sfda.gov.sa and following the links to Medical Devices.

SFDA Medical Device Market Authorisation

The on-line submission of Medical Device Market Authorisation (MDMA) can be found on the SFDA Medical Device website www.sfda.gov.sa.  Submissions must be completed by the Authorised Representative therefore the SFDA urges all manufacturers to engage in the process of approving their Authorised Representative in Saudi Arabia.

Useful contacts:

The SFDA website www.sfda.gov.sa

The SFDA Medical Device webpage http://www.sfda.gov.sa/En/MedicalEquipments

The SFDA Medical Device helpline e-mail addressMDS@sfda.gov.sa