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Demonstration of the Medical Device Post-Market Surveillance Requirements KFYousef Tue, 09/26/2023 – 08:46 Brief: Safety alerts and field safety corrective action (FSCA) for medical devices Reporting and investigation of incidents, adverse events and complaints of medical devices   Work Shop Link Remotely : Click Here     Wed, 09/27/2023 – 10:00 Wed, 09/27/2023 – 11:30 Remotely English Public

The Evolution, Impact and Future of SFDA Laboratories KFYousef Mon, 09/25/2023 – 10:47 Date Mon, 09/25/2023 – 12:00 Image Magazine article type Scientific Magazines magazine files غلاف مجلة اكسفورد_0.pdf (176.42 KB)

Product Recall Guidance KFYousef Thu, 09/21/2023 – 09:51 Product Recall Guidance (1.53 MB) Thu, 09/21/2023 – 12:00 Drugs Guide

Saudi Arabia Hosts Codex Coordinating Committee for Near East (CCNE11) Meeting in Rome KFYousef Mon, 09/18/2023 – 15:24 The Saudi Food & Drug Authority (SFDA) hosts the eleventh meeting of the Codex Coordinating Committee for the Near East (CCNE) on 18–22 September 2023, at FAO headquarters in Rome. During the meeting, SFDA will review the leading experience of Saudi Arabia with the Healthy Food Strategy (HFS) as a key topic aiming to discuss the opportunities for strengthening the role of regional […]

Post Market In-depth Clinical Evaluation for the Safety and the Current Local Practice of Robotically-Assisted Surgical Devices in Mastectomy KFYousef Mon, 09/18/2023 – 15:00 Attachment Post Market In-depth Clinical Evaluation for the Safety and the Current Local Practice of Robotically-Assisted Surgical Devices in Mastectomy (003).pdf (370.09 KB) study date Sun, 09/17/2023 – 12:00 study type Clinical evaluation studies BACKGROUND Robotically-assisted surgical device (RAS) is a new technology with great advantages which holds significant promise. Recently, RAS device is widely used in […]

Product Verification and Validation Requirements for Medical Devices KFYousef Mon, 09/18/2023 – 12:36 Brief: An overview of verification and validation section requirements  Supporting evidence for technical documentation Advice & recommendations   Work Shop Link Remotely : Click Here Tue, 09/26/2023 – 10:00 Tue, 09/26/2023 – 11:00 Remotely English Public

(WU2338) NCMDR Weakly Update KFYousef Mon, 09/18/2023 – 08:17 Date Sun, 09/17/2023 – 12:00 File (WU2338)_0.pdf (793.02 KB)

Post-Market Evaluation for the Safety of Ventilator Associated Pneumonia in the Intensive Care Unit KFYousef Thu, 09/14/2023 – 15:31 Attachment Post-Market Evaluation for the Safety of Ventilator Associated Pneumonia in the Intensive Care Unit.pdf (1.09 MB) study date Thu, 09/14/2023 – 12:00 study type Clinical evaluation studies BACKGROUND The prevalence of ventilator-associated pneumonia (VAP) varies depending on several factors. The estimated prevalence is from 5-40%. This variation depends upon the infection seen in a particular country. In North America, the prevalence […]

Introduction to Pharmacovigilance KFYousef Wed, 09/13/2023 – 15:09 Brief:   • Introduction about SFDA • Introduction about pharmacovigilance in Saudi Arabia • Quality of pharmaceutical products •  Risk Minimization Measures for Medicinal Products • Reporting adverse drug reactions to the SFDA • Cosmetic products safety • Medication errors • Safety information in product label       Work Shop Link Remotely : Click Here Sun, 09/17/2023 – 10:00 Sun, 09/17/2023 – 12:00 Remotely Arabic Public

Are there scientific studies published by the SFDA related to risk analysis and how to find it? KFYousef Wed, 09/13/2023 – 14:43 There are many Published studies. In addition, SFDA have approved scientific papers internally this year. Currently, they are under publishing process in different journals. In addition to one published scientific paper entitled “The occurrence and dietary intake related to the presence of microplastics in drinking water in Saudi Arabia”, It can be found here  DOI: 10.1007/s10661-021-09132-9 Tags Food