Article 27 of the Saudi Medical Devices Law
المادة 27 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المنشأة والممثل المعتمد تزويد الهيئة بكل وثيقة أو معلومة تطلبها للقيام باختصاصاتها 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 27 explained in plain English
This article sets a duty of cooperation with the Authority on two parties:
- The establishment: any legal entity that carries out an activity relating to medical devices and supplies.
- The authorized representative: the legal person authorized by the foreign manufacturer to represent it in the Kingdom.
The duty is to provide the Authority with every document or piece of information it requests. The scope of the request is wide, since the text says "every document or piece of information", but it is limited by its purpose: the request must be for carrying out the Authority's jurisdiction set out in the Law and the Regulations.
The practical benefit is that the Authority cannot carry out its oversight without information, such as import or distribution records or quality documents. This article gives it the legal basis to request them.
The article sets no deadline for responding or particular form for the request, and does not itself address the consequence of not responding. This obligation is linked to Article 15, which makes the authorized representative the foreign manufacturer's representative in matters relating to the application of the Law and the Regulations.
Establishments should keep their documents organized in case the Authority requests them. If an establishment has reservations about a particular request, it can consult a lawyer who specializes in health and commercial regulations.
Practical example
The Authority asked a distribution company in Riyadh for a statement of the quantities of ventilators it distributed during a certain period and the names of the hospitals that received them. The company must provide this information, because the request relates to the Authority's jurisdiction under the Law.
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 27 of the Saudi Medical Devices Law
Must a medical device company provide the documents the Authority requests?
Yes. 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.
Does the obligation cover the authorized representative of a foreign manufacturer?
Yes. The article names the authorized representative expressly alongside the establishment.
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 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.
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.