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Posted 17 February 2015 | By Stewart Eisenhart,
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).
The guidance clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements. Among the key clarifications the SFDA mentions are:
A full list of labeling requirements is available in the SFDA guidance document. For additional information on KSA medical device approval and authorized representation requirements, please refer to our regulatory chart on the Saudi device registration process.
Original Post: Emergo Blog
Related Post: New KSA Declaration of Conformity Requirements for Imported Medical Devices
Related Post: Saudi Arabia Offers Potential for Medical Device Manufacturers
Tags: Emergo, Guidance, Saudi Arabia, Emergo Group, Saudi Food and Drug Authority, SFDA
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