Article 22 of the Saudi Medical Devices Law
المادة 22 من نظام الأجهزة والمستلزمات الطبية
The article requires establishments that want to circulate medical devices and supplies in the Kingdom to apply a quality management system.
Official text (Arabic)
This article has not been amended since the law was issued.
على المنشآت الراغبة في تداول الأجهزة والمستلزمات الطبية في المملكة الالتزام بتطبيق نظام إدارة الجودة.
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 22 explained in plain English
This article requires establishments that want to circulate medical devices and supplies in the Kingdom to apply a quality management system.
Under Article 1, the quality management system is a system approved by the Authority to verify the quality, effectiveness and safety of the medical device or supply, in accordance with the latest version of the technical standard (ISO 13485) or its equivalent, as the Regulations set out.
Important points:
- The obligation falls on establishments that want to circulate, not on the manufacturer alone.
- The reference is the latest version of the standard, or its equivalent.
- The Regulations set out the details, according to the definition.
Circulation under the Law includes making devices available free of charge or for a fee, for distribution or for use. This obligation is linked to other activities in Article 2, including providing services to verify devices' conformity with the quality management system.
Establishments new to this market need to plan to apply the quality system before they begin circulation. To learn exactly what the Regulations require, you can consult a lawyer who specializes in health and commercial regulations.
Practical example
A company in Dammam is preparing to distribute medical supplies to hospitals. Before it starts, it must apply the quality management system the Authority approves, in line with the latest version of ISO 13485 or its equivalent, as the Regulations set out.
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 22 of the Saudi Medical Devices Law
Is ISO 13485 required to circulate medical devices in Saudi Arabia?
The article requires establishments to apply a quality management system, which the Law defines as following the latest version of ISO 13485 or its equivalent, as the Regulations set out.
Who is subject to the obligation to apply the quality system?
Establishments that want to circulate medical devices and supplies in the Kingdom.
More articles on Obligations of the Manufacturer and Authorized Representative
- Article 15
The article requires a manufacturer residing outside the Kingdom that wants to circulate its products there to appoint an authorized representative, subject to the Commercial Agencies Law.
مع مراعاة الأحكام الواردة في نظام الوكالات التجارية؛ يتعين على المصنع المقيم خارج المملكة -عند رغبته في تداول منتجاته في المملكة- تعيين ممثل معتمد له. وتحدد الل
- Article 16
The article requires the manufacturer to provide after-sales services for its medical devices and supplies in accordance with the Law and the Regulations.
على المصنع توفير خدمات ما بعد البيع للأجهزة والمستلزمات الطبية التابعة له، وتطبق في هذا الشأن الأحكام المنصوص عليها في النظام واللائحة.
- Article 17
The article requires establishments to comply with the identifying information that must appear on medical devices and supplies, and refers its determination to the Regulations.
على المنشآت الالتزام بالمعلومات التعريفية الواجب توافرها على الأجهزة والمستلزمات الطبية، وتحدد اللائحة تلك المعلومات.
- Article 21
The article requires the manufacturer to classify medical devices and supplies in accordance with the classification system approved by the Authority.
يلتزم المصنع بتصنيف الأجهزة والمستلزمات الطبية وفقًا لنظام التصنيف.
- Article 27
The article requires the establishment and the authorized representative to provide the Authority with every document or piece of information it requests to carry out its jurisdiction under the Law and the Regulations.
على المنشأة والممثل المعتمد تزويد الهيئة بكل وثيقة أو معلومة تطلبها للقيام باختصاصاتها المنصوص عليها في النظام واللائحة.
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.