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:
- TUV SUD
- TUV Rheinland
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.