Saudi Food and Drug Authority (SFDA) 🇸🇦

Description

The Saudi Food and Drug Authority (SFDA) serves as an autonomous regulatory body within the Kingdom of Saudi Arabia. Its primary objective is to safeguard the safety of food, human and animal pharmaceuticals, biological and chemical substances, and electronic devices pertaining to human health.

Official website

https://www.sfda.gov.sa/en

Weekly reports of the National Center for Medical Devices and Products Reporting

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Weekly reports on safety alerts, recalls, and FSCAs from the National Center for Medical Devices and Products Reporting.

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Updated 4 days ago

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Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Requirements related to clinical trials of medical devices.

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Updated on July 28, 2024

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Guidelines for extending the shelf life of medical devices and supplies during crises, shortages and the like (MDS - G003)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

A document providing guidelines on extending the shelf life of medical devices and supplies during crises and shortages. Type: Guidance.

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Updated on June 2, 2024

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SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

This document provides guidance on SFDA recognized standards for medical device premarket submissions.

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Updated on May 21, 2024

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Authorization to Open Overseas Manufacturer Account Form

From Saudi Food and Drug Authority (SFDA) 🇸🇦

A form for authorizing the opening of an overseas manufacturer account.

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Updated on May 5, 2024

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Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance document outlining regulations for clearance of medicines, medical devices, and food products for pilgrims' use.

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Updated on April 29, 2024

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Guidance on the development of IVDs for in-house use

From Saudi Food and Drug Authority (SFDA) 🇸🇦

A document providing guidance on the development of In Vitro Diagnostics (IVDs) for in-house use.

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Updated on March 5, 2024

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Guidance for Surgical Sutures (MDS-G021)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Document titled "Guidance for Surgical Sutures (MDS-G021)" providing instructions and recommendations related to surgical sutures.

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Updated on March 4, 2024

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Guidance on Biotechnology-based Medical Devices (MDS-G016)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance document (MDS-G016) providing information on biotechnology-based medical devices.

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Updated on February 12, 2024

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(MDS – G009) Guidance for Points of Care (POC) Medical Devices Manufacturing

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance on manufacturing POC medical devices.

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Updated on January 25, 2024

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Guidance on the Procedures for Licensing of Medical Devices and Supplies Establishments

From Saudi Food and Drug Authority (SFDA) 🇸🇦

A document providing guidance on the procedures for licensing medical devices and supplies establishments.

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Updated on January 22, 2024

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Guidance on Medical Devices Samples Collection (MDS-G013)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance on collecting medical device samples.

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Updated on December 20, 2023

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Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS-G017)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance on engaging with healthcare practitioners in Saudi Arabia.

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Updated on November 30, 2023

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Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS-G018)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance on collection of patient experience data.

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Updated on November 30, 2023

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Guidance on Saudi Food and Drug Authority Policy for Engagement with Patients (MDS-G019)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance providing instructions on patient engagement policy.

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Updated on November 30, 2023

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Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Importation and Shipments Clearance requirements for medical devices.

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Updated on October 16, 2023

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Guidance on Manufacturing Paths of Medical Devices (MDS-G011)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guuidance on manufacturing processes for medical devices.

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Updated on October 15, 2023

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Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Guidance on quality assurance programs for radiation emitting and imaging devices as per SFDA requirements.

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Updated on September 28, 2023

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Checklist for Quality Manual Form

From Saudi Food and Drug Authority (SFDA) 🇸🇦

A checklist for a quality manual form.

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Updated on August 6, 2023

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Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3)

From Saudi Food and Drug Authority (SFDA) 🇸🇦

Regulation outlining requirements for safe use of medical devices within healthcare facilities.

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Updated on July 25, 2023

Other (Public Domain)

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