Enews - 05 February 2013
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.
Saudi Food & Drug Authority’s (SFDA) recently introduced Medical Device Regulations, part of which is the Medical Device Market Authorisation (MDMA) system which mandates the granting of a Market Authorisation License for all Medical Devices imported into the Kingdom.
The SFDA’s online system contains the Regulations, Guidance documents etc, more recently an additional Guidance Document (for version 1 of the MDMA database) has been specifically developed by the SFDA in conjunction with the SFDA Designated Conformity Assessment Bodies of which there are currently five ( COSMOS, TUV SUD, TUV Rheinland, SGS and BSI). Version 2 of the MDMA database was released in January 2013 and a guidance document will be available shortly.
This document has 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.
The document is designed to assist you, the applicant, in the completion of the online MDMA Application, indicating what is required. Download your copy.
The SFDA website
The SFDA Medical Device webpage
The SFDA Medical Device email support