By Stewart Eisenhart, Emergo Group
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. Medium-risk medical devices will require valid MDMAs by December 31, 2014. Low-risk IVDs will require MDMAs by June 30, 2015, and low-risk medical devices must have MDMAs starting December 31, 2015.
Manufacturers of affected devices and IVDs should familiarize themselves with SFDA mandatory registration requirements ahead of compliance deadlines, if they haven’t already.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
