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SFDA’s Guidance on Requirements of Shipments Clearance at Ports of Entry

SFDA has recently published a Guidance on the requirements of shipments clearance at Ports of Entry; Click here to read the official document.

Published on: 20th October, 2020

Highlights from this Document

The purpose of this guidance is to clarify the requirements to obtain shipment clearance for products subject to SFDA/MDS regulation at the KSA POEs.

This guidance is applicable to any importer wishes to clear shipments containing products subject to SFDA/MDS regulation at the KSA POEs

For products containing materials subject to the MOI’s control (such
as IVDs and chemicals) require MDIL from SFDA before the referral
to MOI.

The guidance mentions the requirements of clearing shipments at the Port of Entry with regards to the following: Product Shelf Life, Storage and Transportation, Samples Withdrawal and Submitting to SFDA.

The guidance also illustrates the general process flow to assist in deciding the required documents to clear the shipments (Refer to page 10 of the guidance)

In Annex (1) of the attached guidance (Page 12), SFDA has included an example of the Declaration of Conformity to be used in case of clearing Medical Devices at the Port of Entry

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