Article 19 of the Saudi Medical Devices Law
المادة 19 من نظام الأجهزة والمستلزمات الطبية
The article prohibits reprocessing medical devices or supplies intended for single use.
Official text (Arabic)
This article has not been amended since the law was issued.
لا تجوز إعادة معالجة الأجهزة أو المستلزمات الطبية ذات الاستخدام مرة واحدة.
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 19 explained in plain English
This article is a short, absolute prohibition: reprocessing of medical devices or supplies intended for single use is not permitted.
To understand the prohibition we go back to two definitions in Article 1:
- Single-use device: anything made to be used during one medical procedure on one patient, once, and then disposed of.
- Reprocessing: procedures carried out on a previously used device so that it can be reused safely, including cleaning, disinfection, sterilization, and testing and restoring technical functions and safety.
The result is that a tool designed for single use may not be cleaned or sterilized in order to reuse it, even if it appears that sterilization makes it safe. The text sets no exception or condition permitting this.
This differs from the rule in Article 20 on used devices in general, which may not be destroyed, reprocessed, refurbished, sold, lent or donated except under the conditions set by the Regulations. For single-use items, reprocessing is prohibited by the text of Article 19.
The rule protects patients from risks of infection or reduced performance. A person harmed by the reuse of a supply meant for single use may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
A clinic in Riyadh is considering sterilizing acupuncture needles meant for single use and reusing them to save costs. This is prohibited by the text of the article, because reprocessing single-use supplies is not permitted.
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 19 of the Saudi Medical Devices Law
Can single-use supplies be sterilized and reused?
No. The article prohibits reprocessing medical devices or supplies intended for single use, and sterilization is a form of reprocessing under Article 1.
What is the difference between Article 19 and Article 20?
Article 19 prohibits reprocessing single-use items, while Article 20 allows other used devices to be dealt with under the Regulations' conditions.
More articles on Using and Reprocessing Medical Devices
- 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
- Article 26
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.
تراقب الهيئة التزام مقدمي الرعاية الصحية بتطبيق اللوائح الفنية داخل مرافق الرعاية الصحية، للتأكد من سلامة الأجهزة والمستلزمات الطبية ومأمونيتها وكفايتها في التش
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.