Article 45 of the Saudi Medical Devices Law
المادة 45 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
إذا كانت المخالفة مشمولة بحكم الفقرة (2) من المادة (الثانية والأربعين) من النظام، فتحال إلى النيابة العامة؛ للتحقيق فيها، وإحالتها إلى المحكمة المختصة وفقًا للإجراءات النظامية.
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 45 explained in plain English
This article identifies the criminal route for the most serious violations under the Law.
Its scope: the violations covered by paragraph 2 of Article 42, which are the acts in items 1, 2, 3, 7 and 8 of Article 41, whose penalty is imprisonment for no more than 10 years, or a fine of no more than SAR 10 million, or both, with the possibility of additional penalties such as temporary closure, suspension or cancellation of the marketing authorization, barring from the activity and cancellation of the license, and doubling of the penalty in case of repetition.
The procedure:
- The violation is referred to the Public Prosecution to investigate it.
- It is then referred to the competent court.
- This is done in accordance with the legal procedures.
Why this separation? Because the paragraph 2 penalties include imprisonment, which the Authority does not impose. Under Article 43 the Authority is therefore competent to impose only the paragraph 1 penalties, and a grievance against them is made before the committee provided for in Article 44, while paragraph 2 violations go to the courts through the Public Prosecution.
The article does not name the competent court, and uses only the phrase "the competent court". A person referred to the Public Prosecution in a case of this kind needs to consult a lawyer who specializes in criminal cases and health regulations from the investigation stage.
Practical example
The Authority uncovered a network importing counterfeit packaging to pack imitation medical supplies in Jeddah. This is an act under item 7 of Article 41, so it falls under paragraph 2 of Article 42, and the case is referred to the Public Prosecution for investigation and then to the competent 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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Frequently asked questions about Article 45 of the Saudi Medical Devices Law
Are medical device adulteration cases referred to the Public Prosecution?
Yes. Violations covered by paragraph 2 of Article 42 are referred to the Public Prosecution to investigate, and then to the competent court.
Does the Authority impose imprisonment?
Article 43 gives the Authority power to impose only the paragraph 1 penalties. Paragraph 2 violations, which carry imprisonment, are referred to the Public Prosecution and the court.
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 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 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.