Article 18 of the Saudi Medical Devices Law
المادة 18 من نظام الأجهزة والمستلزمات الطبية
The article requires a health care provider not to deal with any establishment in the Law's activities unless it is registered and licensed in the same field of dealing.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم مقدم الرعاية الصحية بألَّا يتعامل مع أي منشأة تزاول أيًّا من الأنشطة الخاضعة للنظام؛ ما لم تكن مسجلة وحاصلة على ترخيص في مجال التعامل نفسه.
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 18 explained in plain English
This article moves part of the oversight responsibility to the health care provider, which under Article 1 is any government or private establishment that provides health care services, such as hospitals, dispensaries and clinics.
It requires the provider not to deal with any establishment carrying out an activity subject to the Law, such as supply, maintenance or inspection, unless it is:
- Registered with the Authority.
- Licensed in the same field of dealing.
The second condition is precise: it is not enough that the establishment holds a license for any activity. Its license must be in the same field in which the hospital deals with it. If it is licensed for distribution, for example, that does not mean it is licensed to provide maintenance services.
This article complements Article 6, which bars the establishment itself from practicing any activity before registration and licensing. The Law bars an unlicensed establishment from working, and bars the health care provider from dealing with it.
The practical effect is that purchasing and maintenance departments in health facilities must check a supplier's registration and license in the field of contracting before dealing with it. If in doubt about the validity of a supplier's license, you can contact the Authority or consult a lawyer who specializes in health and commercial regulations.
Practical example
A private dispensary in Hail wants to contract with a company to maintain sterilization devices. The company is registered and licensed only for distributing supplies. The dispensary may not contract with it for maintenance because it is not licensed in the maintenance field itself.
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 18 of the Saudi Medical Devices Law
Can a hospital buy from an unlicensed medical device supplier?
No. The article requires the health care provider not to deal with any establishment unless it is registered and licensed in the same field of dealing.
Does the article apply to government hospitals?
Yes. Under Article 1, a health care provider includes any government or private establishment that provides health care services.
Is it enough for the supplier to be licensed for any activity?
No. Its license must be in the same field of dealing.
More articles on Registration and Licensing of Establishments
- Article 2
The article lists eight activities that are subject to the Medical Devices and Supplies Law, from design, manufacturing and importing to maintenance and representing a foreign manufacturer.
تخضع لأحكام النظام الأنشطة الآتية: 1- تصميم الأجهزة والمستلزمات الطبية، وتصنيعها. 2- استيراد الأجهزة والمستلزمات الطبية، وتسويقها، وتوزيعها، وتخزينها. 3- تقديم
- Article 6
The article bars any establishment from practicing the Law's activities except after registration and obtaining a license, with an industrial license for factories, subject to Article 4.
مع مراعاة ما ورد في المادة (الرابعة) من النظام؛ لا يجوز لأي منشأة ممارسة أيٍّ من الأنشطة الخاضعة للنظام؛ إلَّا بعد التسجيل، والحصول على الترخيص، إضافةً إلى الحص
- Article 7
The article requires a licensee to obtain the Authority's approval before starting any process of verifying clinical studies, in accordance with the Implementing Regulations.
على المرخص له بإجراء التحقق من الدراسات السريرية؛ الحصول على موافقة الهيئة قبل البدء في أي من عمليات التحقق، وفقًا لما تحدده اللائحة.
- Article 10
The article refers to the Regulations the conditions and procedures for registration, issuing the marketing authorization, and for the license and its renewal, amendment, transfer and cancellation.
تحدد اللائحة الشروط والإجراءات اللازمة للتسجيل، وإصدار الإذن بالتسويق، والحصول على الترخيص وتجديده وتعديله ونقله وإلغائه.
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.