Article 3 of the Saudi Medical Devices Law
المادة 3 من نظام الأجهزة والمستلزمات الطبية
The article treats accessories of medical devices and supplies, and assembled devices, as medical devices and supplies subject to the Law's provisions.
Official text (Arabic)
This article has not been amended since the law was issued.
تعد في حكم الأجهزة والمستلزمات الطبية الخاضعة لأحكام النظام: ملحقاتها، والأجهزة والمستلزمات الطبية المجمعة.
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 3 explained in plain English
This article widens the Law's scope to include two types of products that may not ordinarily be seen as independent medical devices:
- Accessories: under Article 1, any material or product made specifically to be used with a medical device or supply to enable it to achieve the purpose for which it was made.
- Assembled medical devices and supplies: anything put together in a single kit to meet the user's requirements, even if the kit contains devices or supplies that are not medical.
The practical effect is that these two types are treated as medical devices and supplies themselves, so the Law's provisions apply to them. An importer or distributor therefore should not assume that an accessory or kit falls outside the Law merely because it is not a stand-alone medical device, or because some of the kit's contents are not medical.
This article complements Article 2, which set out the activities subject to the Law. Someone who designs, manufactures, imports or distributes accessories or assembled kits is practicing an activity subject to the Law. If you are unsure how to classify a particular product, it is advisable to refer to the Authority or consult a lawyer who specializes in health and commercial regulations.
Practical example
An establishment in Dammam imports a wound-care kit that includes medical dressings, ordinary scissors and a bag. Having non-medical scissors in the kit does not take it outside the Law, because the article treats assembled devices and supplies as medical devices even if they contain non-medical components.
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 3 of the Saudi Medical Devices Law
Are accessories of a medical device subject to the Law?
Yes. The article treats accessories as medical devices and supplies subject to the Law's provisions.
Is a kit that contains non-medical tools subject to the Law?
Yes. Under its definition in Article 1, an assembled device may contain devices or supplies that are not medical, and Article 3 treats it as a medical device.
More articles on Scope and Definitions of the Medical Devices Law
- Article 1
The article defines the key terms of the Medical Devices and Supplies Law, such as medical device, medical supply, adulterated, establishment, authorized representative, marketing authorization and safety alert.
يقصد بالكلمات والعبارات الآتية -أينما وردت في هذا النظام- المعاني المبينة أمام كل منها، ما لم يقتض السياق غير ذلك: النظام: نظام الأجهزة والمستلزمات الطبية. الهي
- 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 4
The article requires the Food and Drug Authority to approve the technical and clinical specifications of radioactive medical materials before they are licensed by the Nuclear and Radiological Regulatory Commission.
مع مراعاة اختصاصات هيئة الرقابة النووية والإشعاعية بإصدار التراخيص اللازمة لممارسة الأنشطة المتعلقة باستخدام المواد الطبية المشعة؛ يشترط موافقة الهيئة على الموا
- Article 5
The article preserves the Nuclear and Radiological Regulatory Commission's jurisdiction to issue the license for protection from ionizing radiation emitted by medical devices, without the Law affecting it.
لا يخل تطبيق أحكام النظام، باختصاصات هيئة الرقابة النووية والإشعاعية فيما يتعلق بإصدار ترخيص الحماية من الإشعاع المؤين الصادر من الأجهزة الطبية.
- Article 48
The article requires the Board to issue the Implementing Regulations within 180 days of the Law's publication in the Official Gazette, to take effect from the date the Law takes effect.
يصدر المجلس اللائحة خلال (مائة وثمانين) يومًا من تاريخ نشر النظام في الجريدة الرسمية، ويعمل بها من تاريخ نفاذه.
- Article 49
The article sets the start of effect of the Medical Devices and Supplies Law at 180 days after its publication in the Official Gazette.
يعمل بالنظام بعد (مائة وثمانين) يومًا من تاريخ نشره في الجريدة الرسمية.
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.