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About SFDA
About SFDA
نظرة عامة
Authority Establishment
Authority Membership
Authority Activities
Authority Management
Board of directors
SFDA in vision 2030
Vision Realization Office
National Transformation Program
Health Sector Transformation Program
National Industrial Development and Logistics Program
Authority Strategy
Strategy
Authority Values
Annual Reports
Career and Life
Life in SFDA
Career General Goals
Information Lists
All
The Authority
Food
Drugs
Medical Devices
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Pesticides
Laboratories
Cosmetics
Tobacco
Halal
Nutrition
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Drugs
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What is the reference number meant in Statement Confirming Saudi Arabia is Not Affected form or Confirmation Statement for Completing the Field Safety Corrective Action form mentioned in the Guidance on Medical Device Field Safety Corrective Actions ?
FAQ
If the Field Safety Notice was sent via e-mail, is receiving the e-mail sufficient for the notification?
FAQ
If the manufacturer determines the time plan to implement the corrective action, does SFDA have the right to reduce the period if it deems it to be?
FAQ
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
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