Guidelines | Saudi Food and Drug Authority

2025-05-21

Medical Devices Guide

Guidance on the development of IVDs for in-house use

2025-03-25

Medical Devices Guide

Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)

2025-03-23

Medical Devices Guide

Guidance on Companion Diagnostic IVDs (MDS-G026)

2025-01-30

Medical Devices Guide

Guidance on Innovative Medical Devices (MDS – G002)

2024-10-01

Medical Devices Guide

Guidance on Content of Labeling of Contact Lenses and its Solutions (MDS-G14)

2024-06-02

Medical Devices Guide

الدليل الارشادي لتمديد فترة صلاحية الأجهزة و المستلزمات الطبية أثناء الأزمات ونقص الامداد وما في حكمها (MDS – G003)

2024-05-21

Medical Devices Guide

SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)

2024-03-04

Medical Devices Guide

Guidance for Surgical Sutures (MDS-G021)

2024-02-12

Medical Devices Guide

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