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SFDA adds requirement for mandatory registration of certain health and herbal products in Saudi Arabia

Issue 10 Sep 2021

The Saudi Food and Drug Authority (SFDA) is an independent regulator of foods, drugs and medical devices in the Kingdom. A major function of the SFDA is to issue national standards and set mandatory standard specifications for these product categories, whether imported or manufactured locally. Moreover, the SFDA is responsible for consumer awareness on all matters related to foods, drugs and medical devices.

Recently, , certain health products must now be registered with the SFDA in order to be marketed in Saudi Arabia. This is contrary to the previous practice wherein such products were only listed on the records/website of the SFDA. Herbal products may also follow the same registration process, subject to evidence of the safety and efficacy of the product.

The registered list for ‘Herbal, Health & Vitamins products’ is available for review for the general consumers on the SFDA website[1].

Health products classified as ‘Subject for Listing’ are submitted to the SFDA under a simplified listing scheme. To classify a product as a health product subject for listing, it must meet a series of criteria and/or be among a specific product category. Conversely, other product categories have been reclassified to ‘Requiring Registration’ and changed the thresholds for registration in other instances. This group of products includes, inter alia, alcohol-based hand sanitizers, throat lozenges, skin care products and herbal oils.

Should you or one of your team members need further information on this, please contact us at dubai@unitedtm.com.