SFDA, The Saudi Food and Drug Authority. The body responsible for regulating, supervising and monitoring food, medicines and medical devices, as well as setting mandatory standards and norms, and for monitoring and/or testing activities in laboratories of the SFDA or other agencies. In addition, the SFDA is responsible for consumer certification in all matters relating to food, drugs and medical devices and all other products and supplies.
The Saudi Medical Devices Sector (MDS) plays a key role in ensuring the safety, efficacy and performance of medical devices under comprehensive legislation and regulation. The Saudi Medical Devices Regulatory Framework is aligned with international practices in terms of harmonisation and convergence, and it chairs the Global Harmonisation Working Party (GHWP) and is an active member of several technical committees of the IMDRF and ISO.
In December 2019, Saudi Arabia launched a new harmonised electronic system ‘GHAD’, which replaces the existing systems for marketing, registration and authorisation of medical devices (MDMA, MDNR and SFDA). From July 2021, local and foreign medical device manufacturers will need to register or renew their licences under the new GHAD system.
It is worth noting that a legal Authorised Representative (AR) needs to be identified locally to communicate with the SFDA for registration certification prior to SFDA registration in Saudi Arabia.