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Legislative Responsibilities

  • Providing technical support to the importers.
  • Set mandatory specifications for medical devices, IVDs, and radiation emitting electronic devices which affect the human health.
  • Set health and good manufacture practice requirements for all medical devices establishments and manufactures
  • Set policies and procedures for medical devices testing.
  • Set requirements for medical devices marketing and distribution and all related issues.
  • Set regulation for medical devices advertizing.

Executive Responsibilities

  • Testing of medical devices, prescription eye glasses, contact lenses, radiation emitting electronic devices that affect human health to ascertain their quality, safety, effectiveness and compliance with mandatory standard approved by the SFDA.
  • Testing of IVDs medical devices to ascertain of their quality, effectiveness and compliance with the manufacturers standards.
  • Registering and testing of medical devices and all related issues.
  • Issuance of marketing authorization for imported medical devices after doing the necessary validation and testing.
  • Permitting the marketing of locally manufactured medical devices, IVDs, prescription eye glasses, contact lenses and their solutions when they have meet the marketing authorization requirements .
  • Establish a central reference laboratory for medical devices in SFDA headquarter, and specialized branched laboratories in the Kingdom’s provinces.
  • Accreditation and licensing the private medical devices laboratories that relate to medical devices work filed.
  • Establish a medical devices database, and exchange information with local, regional and international bodies.
  • Establish a main research center to conduct research and applied study relating to medical devices field.
  • 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.
  • Conduct training programs that enhance the competency of those working in the medical devices field.
  • Promote consumer awareness of medical devices and sector’s responsibilities.
  • Represent the Kingdom of Saudi Arabia in regional and international authorities and organizations relating to the sector’s activities.
  • Establish National Center for Medical Devices Reporting (NCMDR).
  • Establish Medical Devices National Registry. (MDNR)

Surveillance Responsibilities

  • Monitor the implementation of regulations, guidelines and procedures relating to licensing of medical device`s manufactures.
  • Monitor the market of medical devices, IVDs, prescription eye glasses, contact lenses and their solutions to make sure marketed product have SFDA marketing authorization.
  • Inspection of medical devices establishments to assure their compliance with the SFDA requirements.
  • Monitor the market of medical devices, IVDs, prescription eye glasses, contact lenses and their solutions to ensure the establishment have SFDA establishment license.
  • Follow up medical devices recalls with hospitals, healthcare providers in the kingdom, manufacturers and imports and take appropriate corrective and/ or preventive action