ABSTRACT
IVDs, prescription eye glasses, contact lenses and their solutions when they have meet the marketing authorization requirements
6. Establishing a central reference laboratory for medical devices in SFDA headquarter, and specialized branched laboratories in the kingdom’s provinces
7. Accredit and license the private medical devices laboratories that relate to medical devices work field
8. Establish a medical devices database, and exchange information with local, regional and international bodies
9. Establish a main research center to conduct research and applied study relating to medical devices field
10. Conduct researches, studies and provide consultancy services related to medical devices and cooperate with medical devices establishments, authorities, universities, scientific research centers and other institutions conducting similar activities
11. Conduct training programs that enhance the competency of those working in the medical devices field
12. Promote consumer awareness of medical devices and sector’s responsibilities 13. Represent the KSA in regional and international authorities
and organizations relating to the sector’s activities 14. Establish National Center for Medical Devices Reporting
(NCMDR) 15. Establish Medical Devices National Registry (MDNR)
1. Monitor the implementation of regulations, guidelines and procedures relating to licensing of medical device’s manufactures
2. Monitor the market of medical devices, IVDs, prescription eye glasses, contact lenses and their solutions to make sure marketed product have SFDA marketing authorization.
