Article 16 of the Saudi Medical Devices Law
المادة 16 من نظام الأجهزة والمستلزمات الطبية
The article requires the manufacturer to provide after-sales services for its medical devices and supplies in accordance with the Law and the Regulations.
Official text (Arabic)
This article has not been amended since the law was issued.
على المصنع توفير خدمات ما بعد البيع للأجهزة والمستلزمات الطبية التابعة له، وتطبق في هذا الشأن الأحكام المنصوص عليها في النظام واللائحة.
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 16 explained in plain English
This article places on the manufacturer an obligation to provide after-sales services for its medical devices and supplies. Its responsibility does not end with delivering the device to the market.
Under Article 1, a manufacturer is any national or foreign establishment whose purposes include designing medical devices or supplies or manufacturing them to place them on the market under its own name, inside or outside the Kingdom, and manufacturing includes refurbishing, assembling, packing and packaging them and putting identifying information on them. The obligation therefore falls on national and foreign manufacturers alike.
What do after-sales services include? The article does not list them. It provides that the provisions in the Law and the Regulations apply in this regard. The details and level of these services are therefore learned from the Implementing Regulations, and no warranty periods or specific obligations that the text does not contain should be assumed.
This article is linked to Article 15, under which the authorized representative represents the foreign manufacturer inside the Kingdom in matters relating to the application of the Law and the Regulations, and the Regulations determine the obligations and responsibilities of the two parties. A hospital or user that cannot get after-sales service for its device may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
A hospital in Qassim bought ventilators from a particular manufacturer and later needed maintenance and spare parts for them. The article requires the manufacturer to provide after-sales services for its devices, as the Law and the Regulations determine.
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 16 of the Saudi Medical Devices Law
Is the manufacturer required to provide after-sales services for medical devices?
Yes. The article requires the manufacturer to provide after-sales services for its medical devices and supplies.
What do after-sales services include?
The article does not list them, and refers to the provisions in the Law and the 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 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.