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Guidance on Pre-Market Cybersecurity of Medical Devices (MDS-G38)

SFDA pre-market cybersecurity guidance for medical devices

Type	Guideline
Code	MDS-G38
Issuing authority	Ministry of Health (MOH)
Framework	Health data
Tier	Guidelines & circulars
Legal status	In force
Instrument number	MDS-G38 · Saudi Food and Drug Authority (SFDA)
Issued	2019-06-18
Version	1.0
Dates	SFDA, version 1.0, 18 June 2019; guidance
Last verified	2026-10-20

The Saudi Food and Drug Authority (SFDA) guidance MDS-G38 sets pre-market cybersecurity expectations for medical devices.

• Version 1.0, 18 June 2019; guidance.
• Applies to manufacturers seeking marketing authorisation for devices with software or connectivity.

Documents

• Official source (www.sfda.gov.sa)

In this framework

• Law of Ethics of Research on Living Creatures and its Implementing Regulations
• Regulations and Requirements for Conducting Clinical Trials on Drugs (v4.0)
• Saudi Health Information Exchange Policies (IS0303 v1.0)
• MoH internal Data Governance Policy (v0.1)
• Saudi eHealth Security and Privacy Interoperability Specification (IS0101)
• Telehealth Application Guidelines
• Guidance on AI/ML-Enabled Medical Devices (MDS-G010)

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Content and register data licensed CC BY 4.0. Cite the live URL. Machine-readable register (JSON) · Markdown register · Content last verified: 2026-10-21