Mar 31, 2014
The Kingdom of Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has announced when medical device manufacturers must secure valid Medical Device Marketing Authorizations (MDMA) to legally continue selling their products in the KSA.
Saudi regulators already require MDMA registration for high-risk medical and in vitro diagnostic (IVD) devices. Medical devices and IVDs will require valid MDMAs by the following dates:
Manufacturers of affected medical devices and IVDs should familiarize themselves with SFDA mandatory registration requirements ahead of compliance deadlines, if they haven’t already.
The Saudi Food & Drug Authority (SFDA) began requiring foreign medical device manufacturers to provide Declaration of Conformity certificates for all shipments into the Kingdom of Saudi Arabia on January 3, 2014.
Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.