All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
Medium Risk Medical Devices Subject to MDMA Registration in Saudi Arabia by December 31, 2014. IVDs in 2015.
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:
- Medium risk medical devices: December 31, 2014
- Low-risk IVDs: June 30, 2015
- Low-risk medical devices: December 31, 2015
Manufacturers of affected medical devices and IVDs should familiarize themselves with SFDA mandatory registration requirements ahead of compliance deadlines, if they haven’t already.
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