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Saudi Food and Drug Administration

Saudi Regulators Extend Deadline for Low-risk Medical Device Registrations

EMERGO SUMMARY OF KEY POINTS:

  • Saudi regulators have delayed enforcement of a new expedited market pathway for Class I non-sterile, non-measuring medical devices.
  • Starting in September 2018, qualifying devices may apply for listing in the Saudi Medical Device National Registry (MDNR) without undergoing full SFDA review.