Article 44 of the Saudi Medical Devices Law
المادة 44 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 قرارات توقيع العقوبات الصادرة وفقًا للفقرة (1) من المادة (الثانية والأربعين) من النظام.
2- تحدد قواعد وإجراءات عمل اللجنة ومكافآت أعضائها بقرار من المجلس.
3- يجوز الاعتراض على قرارات اللجنة أمام المحكمة الإدارية.
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 44 explained in plain English
This article governs the route of objection to the Authority's penalties, and has three paragraphs:
1. The grievance committee:
- One or more committees are formed by decision of the Board.
- The number of members is not fewer than 3.
- At least one of them is a legal adviser.
- It hears grievances submitted to the Authority against decisions imposing penalties issued under paragraph 1 of Article 42, which are a fine of no more than SAR 5 million, temporary closure, suspension or cancellation of the marketing authorization, barring from the activity, and cancellation of the license.
2. The committee's working rules: its working rules and procedures and its members' remuneration are set by decision of the Board. The deadlines for a grievance and how it is submitted are therefore learned from that decision, not from the Law.
3. Judicial objection: the committee's decisions may be challenged before the Administrative Court.
The path is therefore: a penalty decision from the Authority, then a grievance to the committee, then an objection before the Administrative Court against the committee's decision.
Note that the committee is competent only for paragraph 1 penalties. Paragraph 2 violations, such as adulteration, are referred to the Public Prosecution and the competent court under Article 45. Because grievance deadlines are set by the committee's working rules, a person against whom a decision has been issued is advised to act quickly and consult a lawyer who specializes in administrative cases.
Practical example
The Authority decided to close a pharmacy in Riyadh temporarily for 60 days. Its owner can file a grievance before the competent committee under its rules, and if his grievance is rejected he may challenge the committee's decision before the Administrative Court.
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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Lawyers who handle this kind of case
Dr. Ali Al-Rubaie Law Office and Ittihad Al-Asr Legal Company
Al-Safwa Law Office and Legal Consultancy
Frequently asked questions about Article 44 of the Saudi Medical Devices Law
How do I file a grievance against a Food and Drug Authority penalty on medical devices?
The grievance is submitted to the Authority so that a committee formed by the Board can consider it, under rules and procedures the Board sets by decision.
Can a grievance committee's decision be challenged?
Yes. The committee's decisions may be challenged before the Administrative Court.
What is the deadline for a grievance?
The article sets no period, and refers the committee's rules and procedures to a decision of the Board.
Articles this article refers to
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 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
- Article 47
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.
للمتضرر من أي مخالفة لأحكام النظام، الحق في المطالبة أمام المحكمة المختصة بالتعويض عن الأضرار التي تسببت فيها تلك المخالفة.
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.

