Article 26 of the Saudi Medical Devices Law
المادة 26 من نظام الأجهزة والمستلزمات الطبية
The article gives the Authority power to monitor health care providers' compliance with applying the technical regulations inside their facilities to ensure devices' safety, security and adequacy.
Official text (Arabic)
This article has not been amended since the law was issued.
تراقب الهيئة التزام مقدمي الرعاية الصحية بتطبيق اللوائح الفنية داخل مرافق الرعاية الصحية، للتأكد من سلامة الأجهزة والمستلزمات الطبية ومأمونيتها وكفايتها في التشخيص والعلاج.
This is the official Arabic wording, the only legally binding version. We do not translate the law itself; the explanation below is ours. Official source: Bureau of Experts at the Council of Ministers
Article 26 explained in plain English
This article gives the Saudi Food and Drug Authority jurisdiction to monitor health care providers inside their facilities, not only to monitor manufacturers and suppliers.
Subject of the monitoring: the extent to which health care providers comply with applying the technical regulations inside health care facilities. Under Article 1, the technical regulations are mandatory documents issued by the Authority that set out the principles of safety, performance and manufacturing and the instructions governing them.
The aim of the monitoring, as the article states, is to confirm the:
- Safety of the medical devices and supplies.
- Security of them.
- Adequacy for diagnosis and treatment.
By definition, a health care provider includes both government and private establishments, so the monitoring covers government and private hospitals.
The practical meaning is that oversight of a device does not end when it enters the hospital. How it is operated, maintained and used inside the facility is subject to the technical regulations and to the Authority's oversight. The article does not detail the means of monitoring, and other articles of the Law deal with inspection. Health facilities facing regulatory observations can consult a lawyer who specializes in health and commercial regulations.
Practical example
The Authority visits a private hospital in Jazan to check that dialysis machines are used and managed in line with the technical regulations, to confirm their safety and adequacy for treatment.
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
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Frequently asked questions about Article 26 of the Saudi Medical Devices Law
Does the Food and Drug Authority monitor devices inside hospitals?
Yes. The article gives it power to monitor health care providers' compliance with applying the technical regulations inside their facilities.
Does the monitoring cover government hospitals?
Yes. Under Article 1, a health care provider includes government and private establishments.
What are the technical regulations?
Mandatory documents issued by the Authority that set out the principles of safety, performance and manufacturing and the instructions governing them.
More articles on Using and Reprocessing Medical Devices
- Article 19
The article prohibits reprocessing medical devices or supplies intended for single use.
لا تجوز إعادة معالجة الأجهزة أو المستلزمات الطبية ذات الاستخدام مرة واحدة.
- Article 20
The article bars destroying, reprocessing, refurbishing, selling, lending or donating used medical devices and supplies except under the Regulations' conditions.
لا يجوز إتلاف الأجهزة أو المستلزمات الطبية المستخدمة، ولا إعادة معالجتها، ولا تجديدها، ولا إعادة بيعها، ولا إعارتها، ولا التبرع بها؛ إلَّا وفقًا للشروط التي تحد
- Article 23
The article bars dispensing medical devices and supplies classified as high-risk for use outside a health care establishment without a medical prescription, and the Authority issues the list of them.
لا يجوز صرف الأجهزة أو المستلزمات الطبية المصنفة عالية الخطورة -وفقًا لنظام التصنيف- للاستخدام خارج منشأة مقدم الرعاية الصحية؛ دون وصفة طبية. وتصدر الهيئة قائمة
The texts are reproduced from the official website of the Bureau of Experts at the Council of Ministers for reference; where they differ, the officially published Arabic text prevails. This content is not legal advice.