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Is it required to provide a risk assessment form with each Field Safety Corrective Action? FAQ

If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not? FAQ

In case of receiving inquiries from SFDA about a medical device Field Safety Corrective Action that they received from more than one source, but for the company is considered as one Field Safety Notice should all of them be closed, or it should be reported that they are the same Field Safety Notice which was previously answered? FAQ

In the event that a corrective action is issued by the factory, is it necessary for affected customers to be notified immediately even before the corrective plan is provided? FAQ

If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action? FAQ

In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure? FAQ

If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure? FAQ

(SG-2008-257-H) Black dirt in water of Hydrox Medical Report

Drug Master File : Guidance for Submission Regulations

Guidance for Priority Review of Product Registration Regulations