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Law of Ethics of Research on Living Creatures and its Implementing Regulations

Research ethics rules, including sample export (M/59; NCBE)

Type	Law
Issuing authority	Ministry of Health (MOH)
Framework	Health data
Tier	Primary law: niẓām (Royal Decree M/…)
Legal status	In force
Instrument number	M/59 · Royal Decree; National Committee of Bioethics (NCBE)
Version	IR v3 (2025)
Dates	Royal Decree M/59; Implementing Regulations v3 (2025); in force (reported)
Last verified	2026-10-20

The Law of Ethics of Research on Living Creatures (Royal Decree M/59) and its Implementing Regulations govern research on humans and other living creatures. The National Committee of Bioethics (NCBE) oversees them. Details are from a secondary host of the text.

• Implementing Regulations version 3 (2025); reported as in force.
• Only coded samples may be sent abroad.
• Sending samples abroad needs written committee authorisation and a material transfer agreement (MTA).
• Samples may not be stored offshore after analysis.

In this framework

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

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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