Regulations | Saudi Food and Drug Authority

2020-11-23

Medical Devices Guide

Guideline of Import and Clearance Requirements for Particle Accelerators Used in Radioisotope Formation for Medical Applications

2020-11-09

Medical Devices Procedural rule

Implementing Rule on SFDA’s Requirements for Quality Management System Auditing Organizations

2020-10-28

Medical Devices Guide

Guidance on Requirements for Medical Masks - Recognized Standards

2020-10-20

Medical Devices Guide

Guidance on Shipment Clearance at Ports of Entry

2020-09-20

Medical Devices Requirement

Guidance on Requirements for Electronic Instructions for Use (e-IFU) of Medical Devices

2020-09-20

Medical Devices Guide

Guidance on Requirements for Reporting and investigation of Incidents and Adverse Events of Medical Devices

2020-09-16

Medical Devices Guide

SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)

2020-09-10

Medical Devices Guide

Guidance on Requirements for Clinical Investigations (Trials) of Medical Devices

2020-09-07

Medical Devices Guide

Temporary Guidance on Corona Virus (Covid-19) IVD Tests - Emergency Use Authorization (EUA)