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Posts in Category: Insights

Breakthrough Medicines Designation in SFDA
Implementing PMCF Study for Medical Devices in Saudi Arabia
Drug Information and Stock Reporting to SFDA (SDI) Platform
Saudi Pharmacovigilance Sub System File (PSSF)
Product Recall in Saudi Arabia
SDEA Agreement Requirements by SFDA
SFDA Timelines
SFDA Reference Countries
Submission of Individual Case Safety Reports (ICSRs) to SFDA
Periodic Safety Update Report (PSUR) Submission to SFDA
Medical Gas Registration
SFDA Labelling Requirements (SPC, PIL, IFU, Artworks)

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