Healthcare, Industry News, Medical Devices, Regulatory Affairs

SFDA: some borderline products shall be regulated as drugs rather than medical devices

The SFDA now regulates some borderline products as drugs rather than medical devices.

The Saudi Arabian government has officially declared that it considers certain borderline products from medical device to be regulated as per pharmaceutical regulations according to a recent circular from the Saudi Food and Drug Authority (SFDA)

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)

For the affected products currently registered with the SFDA as medical devices, their registrations will remain valid until the validity of the registrations.

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