Saudi FDA to Regulate Borderline Products as Pharmaceuticals


  • The Saudi Food and Drug Authority (SFDA) now regulates some borderline products as drugs rather than medical devices.
  • For affected products currently registered with the SFDA as medical devices, their registrations will remain valid until they expire.

Saudi Arabia regulates borderline products as drugs nowThe Saudi Arabian government has officially shifted oversight of certain borderline products from medical device to pharmaceutical regulation.

A recent circular from the Saudi Food and Drug Authority (SFDA) (link in Arabic) explains that the products identified below may no longer be registered as medical devices in the country:

  • Nasal preparations (normal saline products)
  • Ear preparations (normal saline products)
  • Eye preparations (having direct contact with the eye)
  • Injection products (hyaluronic acid and botulinum toxin injections)

Instead, the SFDA now regulates these borderline products as drugs. However, existing medical device registrations for these products will remain valid until they expire, at which point registration holders will have to submit new applications for approval according to SFDA pharmaceutical requirements.

According to Emergo consultants in Riyadh, some manufacturers had previously registered these products as medical devices, while others had registered them as drugs. Thus, the SFDA revised its stance on borderline products to address ongoing issues regarding conflicting regulatory requirements and pricing.

For more details on Saudi Arabia’s medical device approval process, download our whitepaper or watch our video overview.

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