Article 15 of the Saudi Medical Devices Law
المادة 15 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 اللائحة الشروط اللازم توافرها في الممثل المعتمد، وكذلك التزامات الطرفين ومسؤولياتهما.
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 15 explained in plain English
This article addresses the position of foreign manufacturers. If a manufacturer residing outside the Kingdom wants to circulate its medical devices and supplies inside the Kingdom, it must appoint an authorized representative.
Under Article 1, the authorized representative is a legal person based in the Kingdom, authorized in writing by the manufacturer to represent it inside the Kingdom in matters relating to the application of the Law and the Regulations. The representative must therefore be a legal entity, not an individual, must be based inside the Kingdom, and its authorization must be in writing.
The article leaves two matters to the Implementing Regulations:
- The conditions the authorized representative must meet.
- The obligations and responsibilities of the two parties, the manufacturer and the representative.
The article begins with the phrase "subject to the provisions of the Commercial Agencies Law", meaning that appointing an authorized representative does not displace the application of that law's provisions where they apply. Note that representing a manufacturer residing outside the Kingdom is one of the activities subject to the Law under Article 2.
The authorized representative is also subject to other obligations in the Law, such as providing the Authority with the documents it requests under Article 27. To draft the representation contract, it is advisable to use a lawyer who specializes in health and commercial regulations.
Practical example
A German manufacturer of electrocardiogram devices wants to sell its products in the Kingdom. It must authorize in writing a company based in Riyadh to be its authorized representative, subject to the Commercial Agencies Law, and meet the Regulations' conditions for the representative.
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 15 of the Saudi Medical Devices Law
Does a foreign manufacturer need a representative in Saudi Arabia?
Yes. If it wants to circulate its products in the Kingdom, it must appoint an authorized representative under Article 15.
Can the authorized representative be an individual?
The definition in Article 1 requires it to be a legal person based in the Kingdom and authorized in writing.
Where do I find the conditions for the authorized representative?
The article refers the determination of its conditions and the obligations and responsibilities of the two parties to the Implementing Regulations.
More articles on Obligations of the Manufacturer and Authorized Representative
- 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 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.