The Kingdom of Saudi Arabia (KSA) Food and Drug authority (SFDA) is still constructing the regulatory infrastructure for medical device registration. A local representative is required to handle the registration application on behalf of the foreign manufacturer. Manufacturer registration and product listing is part of the overall requirements.

Medical devices, which are presently allowed on the KSA market, may continue to be marketed, however, after February 28, 2011 only medical devices that have obtained an SFDA marketing authorization may be sold. Moreover, after June 30, 2011 only SFDA authorized medical devices may be put into service within the KSA, while devices in use at that date may continue to be utilized. 

Only medical devices that have been authorized by one of the Founding Members of the Global Harmonization Task Force (GHTF) will have access to the KSA market. Our country specific (*) regulatory services in Saudi Arabia include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with SFDA, local Representative and certification holder for Medical Device manufacturers, KSA FDA Technical documents preparation and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in The Kingdom of Saudi Arabia!

(*) Saudi Arabian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.