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Saudi FDA to Regulate Combination Products as Pharmaceuticals

October 12, 2016

The Saudi Arabian FDA has shifted oversight of certain combination products from medical device to pharmaceutical regulation.

A recent circular from the Saudi Food and Drug Authority identified the products as: nasal preparations, ear preparations, eye preparations (having direct contact with the eye) and injection products (hyaluronic acid and botulinum toxin injections).

Existing medical device registrations for these combination products will remain effective until they expire, at which point registration holders will have to submit new applications for approval according to Saudi FDA pharmaceutical requirements. — Cynthia Jessup

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