Article 17 of the Saudi Medical Devices Law
المادة 17 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المنشآت الالتزام بالمعلومات التعريفية الواجب توافرها على الأجهزة والمستلزمات الطبية، وتحدد اللائحة تلك المعلومات.
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 17 explained in plain English
This article concerns what is written on the medical device or supply, which the Law calls identifying information. Under Article 1, it is any statement or information drawn, pictured, written or printed on the device, and includes:
- Information identifying it.
- Its technical description.
- How to use it.
- Methods of storing and transporting it.
The article requires establishments to comply with the identifying information that must be provided. An establishment, by definition, is any legal entity that carries out an activity relating to medical devices and supplies, so the obligation is not limited to the manufacturer but includes, for example, the importer and the distributor.
As for determining this information in detail, such as the required language or the mandatory data, the article refers it to the Regulations. Note also that the definition of technical regulations in Article 1 lists identifying information requirements among what those mandatory documents address.
The importance of this obligation for the user is that the identifying information is what tells him the correct way to use the device and store it safely. An establishment that imports products with incomplete labels may need to consult the Regulations or a lawyer who specializes in health and commercial regulations.
Practical example
A distributor in Jeddah imports asthma inhalers. Before distributing them, it must make sure they carry the identifying information that the Regulations determine, such as information identifying the device, how to use it, and methods of storing and transporting it.
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 17 of the Saudi Medical Devices Law
What is the identifying information on a medical device?
Under Article 1, it is the data written, printed or pictured on the device, and includes identification of it, its technical description, how to use it, and methods of storing and transporting it.
Who must comply with the identifying information?
The article requires establishments, meaning every legal entity that carries out an activity relating to medical devices and supplies.
Where do I find the list of required information?
The article refers the determination of this information to the Implementing Regulations.
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 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 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.