Article 21 of the Saudi Medical Devices Law
المادة 21 من نظام الأجهزة والمستلزمات الطبية
The article requires the manufacturer to classify medical devices and supplies in accordance with the classification system approved by the Authority.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم المصنع بتصنيف الأجهزة والمستلزمات الطبية وفقًا لنظام التصنيف.
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 21 explained in plain English
This article places on the manufacturer an obligation to classify its medical devices and supplies in accordance with the classification system.
Under Article 1, the classification system is a system approved by the Authority that works to:
- Assess the degree of risk associated with the medical device or supply.
- Assess its safety.
The manufacturer does not classify its products by criteria of its own choosing, but according to the system the Authority approves. This classification matters because other provisions of the Law depend on it. For example, Article 23 bars dispensing devices classified as high-risk under the classification system for use outside the health care provider's establishment without a medical prescription.
By definition, a manufacturer includes national and foreign establishments that design devices or manufacture them to place them on the market under their own name, inside or outside the Kingdom. The obligation therefore falls on all of them.
The article does not set out the classification categories or detailed criteria. These are determined by the classification system the Authority approves. A manufacturer that disagrees with the Authority about the classification of a product may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
A start-up manufacturer in Riyadh produces medical adhesive strips and pulse monitors. It must classify each product under the classification system the Authority approves, to determine its degree of risk and assess its safety.
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 21 of the Saudi Medical Devices Law
Who classifies medical devices by risk?
The article requires the manufacturer to classify medical devices and supplies in accordance with the classification system the Authority approves.
Why is classification important?
Because other provisions depend on it, such as Article 23, which bars dispensing high-risk devices outside a health care establishment without a medical prescription.
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 22
The article requires establishments that want to circulate medical devices and supplies in the Kingdom to apply a quality management system.
على المنشآت الراغبة في تداول الأجهزة والمستلزمات الطبية في المملكة الالتزام بتطبيق نظام إدارة الجودة.
- 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.