Regulatory documents & guidelines

SFDA requirements, sent to your inbox.

Official regulations, requirements and guidelines published by the Saudi Food and Drug Authority. Find the document you need and we’ll email it to you.

Category

11 documents

Medical devices

Requirements for Safe Use of Medical Devices Inside Healthcare Facilities

MDS-REQ3 · Updated 2 Aug 2026

Medical devices

Requirements for Obtaining SFDA Approval for Advertisement and Launching Awareness and Charitable Campaigns for Medical Devices

MDS-REQ8 · Updated 20 Jul 2026

Medical devices

Requirements for Clinical Trials of Medical Devices

MDS-REQ2 · Updated 22 Jun 2025

Medical devices

Requirements on Importation and Shipments Clearance of Medical Devices

MDS-REQ5 · Updated 16 Oct 2023

Medical devices

Requirements for Post-Market Surveillance of Medical Devices

MDS-REQ11 · Updated 28 Mar 2023

Medical devices

Requirements for Licensing of Medical Devices Establishments

MDS-REQ9 · Updated 18 Aug 2022

Food

Conditions & Requirements for Importing Food to Saudi Arabia

Updated 17 Mar 2022

Cosmetics

Conditions of Cosmetic Products Clearance and Raw Materials Used in Their Manufacturing

Updated 8 Mar 2022

Medical devices

Requirements for Medical Devices Marketing Authorization

MDS-REQ1 · Updated 19 Dec 2021

Medical devices

Implementing Regulation of the Law of Medical Devices

Updated 27 Sept 2021

Cosmetics

Implementing Regulation of Cosmetic Products Law

Updated 8 Mar 2016

These documents are published by the Saudi Food and Drug Authority (SFDA). Always check the SFDA website for the latest version.

Start with step one

Book an initial consultation.

Tell us about your portfolio and timeline. A specialist will map the regulatory pathway with you.

Talk to a specialistinfo@i-regulations.com
+966 53 530 0129