Article 47 of the Saudi Medical Devices Law
المادة 47 من نظام الأجهزة والمستلزمات الطبية
The article recognizes the right of anyone harmed by a violation of the Law to claim compensation before the competent court for the damage the violation caused.
Official text (Arabic)
This article has not been amended since the law was issued.
للمتضرر من أي مخالفة لأحكام النظام، الحق في المطالبة أمام المحكمة المختصة بالتعويض عن الأضرار التي تسببت فيها تلك المخالفة.
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 47 explained in plain English
This article protects the injured person by giving him the right to claim compensation.
Elements of the rule:
- Who may claim? Anyone harmed by any violation of the Law's provisions. The text is general, and covers the patient, the user or an establishment that suffered damage.
- What may he claim? Compensation for the damage that violation caused. There must be a causal link between the violation and the damage.
- Where? Before the competent court. The article does not name the court.
The relationship with penalties: the penalties in Article 42 protect the public interest, whereas compensation protects the private interest of the injured person. A penalty imposed on the violator by the Authority or the court does not itself compensate the injured person, so he needs to claim his right before the competent court.
If the injured person bought a device that was adulterated, unregistered or without the marketing authorization, Article 14 requires the seller to refund the price. This does not prevent claiming compensation for other damage under this article.
The article does not set how compensation is assessed. A person harmed by a violating medical device is advised to consult a lawyer who specializes in civil cases and compensation.
Practical example
Fahd in Riyadh suffered burns from a home physiotherapy device that turned out to be adulterated. Besides the penalty that may be imposed on the seller, Fahd is entitled to claim before the competent court compensation for the damage this violation caused.
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 47 of the Saudi Medical Devices Law
Am I entitled to compensation if I was harmed by a violating medical device?
Yes. Anyone harmed by any violation of the Law's provisions has the right to claim compensation before the competent court for the damage the violation caused.
Does the violator's penalty replace compensation?
No. The article recognizes the injured person's right to claim compensation independently before the competent court.
What is the difference between a refund of the price and compensation?
Article 14 requires the seller of an adulterated or unregistered device to refund the price, whereas Article 47 allows a claim for compensation for the damage the violation caused.
More articles on Grievances Against Authority Penalties and Compensation
- Article 43
The article gives the Authority power to impose the penalties in paragraph 1 of Article 42 under a violations table issued by the Board that takes account of seriousness and circumstances, with precautionary measures permitted.
تتولى الهيئة توقيع العقوبات المنصوص عليها في الفقرة (1) من المادة (الثانية والأربعين) من النظام، وذلك وفقًا لجدول يصدره المجلس يتضمن تصنيفًا للمخالفات والعقوبات
- Article 44
The article creates a committee to hear grievances against penalty decisions under paragraph 1 of Article 42, and its decisions may be challenged before the Administrative Court.
1- تكوَّن بقرار من المجلس لجنة (أو أكثر) لا يقل عدد أعضائها عن (ثلاثة)، يكون أحدَهم -على الأقل- مستشارٌ نظاميٌّ؛ للنظر في التظلمات التي تقدم إلى الهيئة من قرارا
- Article 45
The article refers the violations covered by paragraph 2 of Article 42 to the Public Prosecution to investigate and refer to the competent court under the legal procedures.
إذا كانت المخالفة مشمولة بحكم الفقرة (2) من المادة (الثانية والأربعين) من النظام، فتحال إلى النيابة العامة؛ للتحقيق فيها، وإحالتها إلى المحكمة المختصة وفقًا للإ
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.