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New KSA Declaration of Conformity Requirements for Imported Medical Devices

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Update: Declaration of Conformity requirements went into effect on January 3, 2014.

The Saudi Food & Drug Authority (SFDA) began requiring foreign medical device manufacturers to provide Declaration of Conformity certificates for all shipments into the Kingdom of Saudi Arabia January 3, 2014.

The new requirement applies to foreign manufacturers that have already obtained market authorization in the KSA. Acceptable documentation must declare that manufacturers’ devices comply with the KSA’s Medical Devices Interim Regulation and are registered with the SFDA.

Declarations must also identify manufacturers’ KSA Authorized Representatives, importers and SFDA-assigned identification numbers. The SFDA has provided a template declaration with its announcement; these documents should be included in device shipments to Saudi Arabia.

How might this new requirement affect foreign manufacturers’ KSA business? It may actually help expedite the importation process, according to Emergo Group sources in Riyadh. We’ll report back once the new SFDA requirement has taken full effect.

Stewart Eisenhart

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