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The technical regulation SFDA.FD/GSO 9 “Labeling of Prepackaged Food Stuffs” has stated “Labelling and adjoining explanatory statements shall be in Arabic and, where another language is used, it shall be alongside the Arabic ,All the information provided in another language shall be identical with those written in Arabic”

Yes, based on bundling/grouping criteria on guidance MDS-G7:

https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf

The Technical Regulation SFDA.FD 147 “Honey” stated that adding food ingredients to honey is prohibited.

Yes. This can be done by clicking on "Preview" button that is founded next to the standard's subject, where the standard's foreword, scope and other  information  will appear.

means any malfunction or deterioration in the characteristics or
performance of a device made available on the market, including use-error
due to ergonomic features, as well as any inadequacy in the information
supplied by the manufacturer and any undesirable side-effect

Yes, and they should be informed again if there are additional corrective or preventive recommendations or actions.

Yes, KSA is considered as not affected.

The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.

All clearance conditions and requirements shall be met by both the exporter and importer. 



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