In brief
Regulates marketing, import, manufacture and maintenance of medical devices and supplies, licensing establishments, post-market surveillance and violations.
Summary of the law
Key points
- Fines can reach SAR 5 million with other penalties (Article 42), and informants may get up to 25% of the fine (Article 37).
An advisory summary prepared by Al-Bayan Al-Wadih Law Firm. It is not an official text and does not replace the law, its implementing regulations, or advice from a specialised lawyer. The official published text and its amendments prevail.
What it covers
- Covered activities
- Establishment licences
- Post-market surveillance
- Penalties
Timeline
- Issued: Royal Decree M/54 · 6/7/1442H
Full record of amendments and regulations at the official source
Official text at the Bureau of Experts
The authoritative text is in Arabic; the Bureau of Experts publishes English translations for some laws.
Full official text
The full official text is in Arabic and is reproduced on the Arabic version of this page, as published by the Bureau of Experts at the Council of Ministers. Read the full Arabic text
Library content is simplified general information for awareness only. It is not legal advice and does not replace the official text. Laws change: always check the official source and consult a lawyer before acting. Library data last reviewed: .