Article 46 of the Saudi Medical Devices Law
المادة 46 من نظام الأجهزة والمستلزمات الطبية
The article allows a judgment or penalty decision to include publishing its operative part, at the violator's expense, in a local newspaper or another suitable medium, after it becomes final.
Official text (Arabic)
This article has not been amended since the law was issued.
يجوز تضمين الحكم أو القرار الصادر بالعقوبة -بحسب الأحوال- النص على نشر منطوقه على نفقة المخالف في صحيفة محلية تصدر في مقر إقامته، فإن لم تكن في مقره صحيفة ففي أقرب منطقة إليه، أو على نشره في أي وسيلة أخرى مناسبة، وذلك بحسب نوع المخالفة المرتكبة وجسامتها وتأثيرها؛ على أن يكون النشر بعد اكتساب الحكم الصفة القطعية، أو تحصُّن القرار بفوات ميعاد التظلم منه، أو صدور حكم نهائي برفض التظلم منه.
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 46 explained in plain English
This article concerns publishing the penalty, an effect that goes beyond the penalty itself because it affects the violator's reputation.
The basic rule: the judgment or decision imposing the penalty, as the case may be, may include a provision for publishing its operative part at the violator's expense.
Means of publication:
- A local newspaper published where the violator resides.
- If there is no newspaper where he resides, in the nearest region to him.
- Or in any other suitable medium.
Standard of assessment: according to the type of violation and its seriousness and effect. Publication is discretionary and decided case by case.
Timing of publication, which is an important safeguard: publication takes place only after one of the following:
- The judgment becomes final.
- The decision becomes immune because the deadline for a grievance against it has passed.
- A final judgment is issued rejecting the grievance against it.
The practical meaning is that the violator is not publicly named while the route of challenge remains open, so that his name is not published and it is later found that the penalty was cancelled. The article is linked to Article 44, which governs grievances against penalty decisions before the committee and objection before the Administrative Court.
An establishment facing a penalty with the possibility of publication may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
A fine was decided on an establishment in Hail for a serious violation, and the decision included publishing its operative part in a local newspaper at its expense. The establishment did not file a grievance until the deadline passed, so the decision became immune and publication became possible, and the establishment bears its costs.
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 46 of the Saudi Medical Devices Law
Are the penalties of those who violate the Medical Devices Law published?
The judgment or decision may include publishing its operative part at the violator's expense, according to the type of violation and its seriousness and effect.
When is the penalty published?
After the judgment becomes final, or the decision becomes immune because the deadline for a grievance has passed, or a final judgment is issued rejecting the grievance.
Who bears the cost of publication?
The violator, according to the text of the article.
More articles on Medical Device Fraud Violations and Penalties
- Article 14
The article requires anyone who dispensed or sold an adulterated, unregistered or unauthorized medical device to notify the Authority as soon as he learns of it and to refund the buyer's price.
على كل من صرف أو باع جهازًا أو مستلزمًا طبيًّا مغشوشًا، أو غير مسجل، أو غير حاصل على الإذن بالتسويق، إبلاغ الهيئة -فور علمه بذلك- بالمعلومات التي تتعلق بما صُرف
- Article 41
The article lists the acts that are violations of the Medical Devices Law, such as adulteration, selling adulterated items, bringing in unregistered ones, false promotion and breaching transport and storage conditions.
يعد مخالفًا لأحكام النظام كل مَن: 1- غش أو شرع في غش أي جهاز أو مستلزم طبي. 2- باع، أو صرف، أو حاز بقصد الاتجار أجهزة أو مستلزمات طبية مغشوشة مع علمه بذلك. 3- أ
- Article 42
The article sets the penalties for violations of the Law: a fine of up to five million riyals, closure, suspension and cancellation, and up to ten years in prison or a fine of up to ten million for adulteration offenses.
1- دون إخلال بأي عقوبة أشد ينص عليها أي نظام آخر، يعاقب كل من يرتكب أي مخالفة لأحكام النظام أو اللائحة، بواحدة أو أكثر من العقوبات الآتية: أ- غرامة لا تزيد على
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.

