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Category: Regulatory Affairs

 Updated on: 07/07/2024
Scientific Office Requirements by SFDA
 Updated on: 06/07/2024
Reporting Medical Device Incidents & Adverse Events to SFDA
 Updated on: 06/07/2024
Breakthrough Medicines Designation in SFDA
 Updated on: 06/07/2024
Post-Market Clinical Follow-Up (PMCF) according to SFDA
 Updated on: 06/07/2024
Understanding Orphan Drug Designation (ODD) in SFDA
 Updated on: 06/07/2024
Drug Information and Stock Reporting to SFDA (SDI)
 Updated on: 06/07/2024
Saudi PV Sub System (PSSF)
 Updated on: 06/07/2024
Product Recall in Saudi Arabia
 Updated on: 06/07/2024
SFDA Timelines
 Updated on: 06/07/2024
SFDA Reference Countries
 Updated on: 07/07/2024
SFDA stops the listing procedure of low risk medical devices
 Updated on: 06/07/2024
Medicinal Gases Registration
 Updated on: 06/07/2024
SFDA Labelling Requirements
 Updated on: 30/07/2022
SFDA Clinical Trials Requirements in Saudi Arabia
 Updated on: 06/07/2024
SFDA Food Supplements Registration
 Updated on: 21/01/2024
SFDA UDI Requirements for Medical Devices
 Updated on: 25/03/2024
SFDA Fees: Drug, Medical Device, and Food Applications
 Updated on: 25/01/2024
SFDA Variation Guidelines (Version 6.2)
 Updated on: 16/03/2024
SFDA Verification & Abridged Procedure
 Updated on: 16/03/2024
SFDA Stability Study Requirements
 Updated on: 16/03/2024
SFDA Classification
 Updated on: 30/07/2022
SFDA GMP: Manufacturer Registration in Saudi Arabia
 Updated on: 26/04/2023
SFDA Priority Review: 40% Faster Registration
 Updated on: 26/04/2023
How to Develop a Regulatory Strategy for the Saudi Market
 Updated on: 22/07/2024
SFDA Registration and Approval Process
 Updated on: 13/07/2024
SFDA Medical Device Registration
 Updated on: 13/07/2024
SFDA Drug Registration Requirements
 Updated on: 13/07/2024
SFDA Cosmetics Registration
 Updated on: 13/07/2024
Medical Device Authorised Representative in Saudi Arabia (SFDA)
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