Guidelines  / Date of Publishing: 10/11/2021

Affected region: KSA

Guidance for Borderline Products Classification

This guidance addresses the Saudi Food and Drug Authority’s (SFDA) current understanding of borderline products; and helps to clarify the areas where the borderline exists between two or more regulations. Moreover, this guidance explains the classification criteria and the approach to determine the most appropriate regulatory path when there is doubt or difficulty in classification.

This guidance document pertains to a product or category of products that is under the responsibility of each sector within SFDA regulation.