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Saudi Arabian Regulators May Exempt Some Low-Risk Medical Devices from MDMA Registration

EMERGO SUMMARY OF KEY POINTS:

  • Saudi medical device regulators have unofficially indicated they may soon exempt certain Class I devices from MDMA registration requirements.
  • Class I non-sterile, non-measuring devices would still require Saudi Arabia Authorized Representation in order to be commercialized in the country.
  • The Saudi Food and Drug Authority (SFDA) may push through the new exemption in the next month or two.

Saudi Food and Drug Authority (SFDA) exempting some Class I medical devices from MDMA requirements 2017Regulators at the Saudi Food and Drug Authority (SFDA) may soon exempt some Class I medical devices from registration requirements according to Emergo sources in Riyadh.

The SFDA has yet to issue a formal announcement, but based on verbal internal discussions Emergo consultants have learned that Class I non-sterile, non-measuring devices could be exempt from Medical Device Marketing Authorization (MDMA) requirements in Saudi Arabia by as early as October or November 2017.

Furthermore, new SFDA guidance on shipment clearances at Saudi ports of entry states that low-risk non-sterile, non-measuring devices imported and sold in the country will not require MDMAs. However, the new guidance also includes requirements that such devices will require listing in the soon-to-be-launched SFDA Medical Device National Registry (MDNR) as well as Saudi Arabia Authorized Representation in order to be marketed in the country.

Emergo consultants will provide additional updates on MDMA exemptions for Class I non-sterile, non-measuring devices once the SFDA issues official guidance.

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