Article 41 of the Saudi Medical Devices Law
المادة 41 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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- أدخل إلى المملكة جهازًا أو مستلزمًا طبيًّا غير مسجل، أو مغشوشًا، أو غير حاصل على إذن تسويق، أو حاول إدخال أيٍّ من ذلك.
4- صنع جهازًا أو مستلزمًا طبيًّا بالمخالفة لأي حكم من أحكام النظام واللائحة واللوائح الفنية.
5- استعمل للترويج للأجهزة والمستلزمات الطبية معلومات غير حقيقية، سواء عليها، أو في الدعاية لها.
6- نقل أو خزَّن جهازًا أو مستلزمًا طبيًّا بالمخالفة لشروط النقل والتخزين التي تحددها الهيئة.
7- أدخل إلى المملكة عبوات أو أغلفة لجهاز أو مستلزم طبي بقصد الغش، أو حاول إدخال أي من ذلك.
8- صنع أو طبع أو حاز أو باع أو عرض عبوات أو أغلفة لجهاز أو مستلزم طبي بقصد الغش.
9- ارتكب أي مخالفة أخرى لأحكام النظام.
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 41 explained in plain English
This article sets out the list of acts whose perpetrator is considered a violator of the Law's provisions:
- Adulterating any medical device or supply, or attempting to adulterate it.
- Selling, dispensing or possessing with intent to trade adulterated devices or supplies with knowledge of that.
- Bringing a device or supply that is unregistered, adulterated or without a marketing authorization into the Kingdom, or attempting to.
- Manufacturing a device or supply in breach of any provision of the Law, the Regulations or the technical regulations.
- Using untrue information to promote, whether on the device or in advertising for it.
- Transporting or storing a device or supply in breach of the transport and storage conditions set by the Authority.
- Bringing in packaging or wrappers with intent to deceive, or attempting to.
- Making, printing, possessing, selling or displaying packaging or wrappers with intent to deceive.
- Committing any other violation of the Law's provisions.
Important notes:
- In item 2 the text requires knowledge that the devices are adulterated, and in the case of possession requires that it be with intent to trade.
- In items 7 and 8 intent to deceive is required.
- Attempts are punishable in the cases the text mentions (items 1, 3 and 7).
- Item 9 makes any other violation of the Law a violation.
Article 42 sets the penalties, and provides a heavier penalty for the acts in items 1, 2, 3, 7 and 8. A person facing an accusation of one of these violations needs to consult a lawyer who specializes in criminal cases and health regulations.
Practical example
A shop owner in Jeddah bought a quantity of medical masks at a very low price knowing they were in counterfeit packaging, and then offered them for sale. His act falls under item 2 (possessing adulterated supplies with intent to trade, with knowledge), and may also fall under item 8 (possessing or selling packaging with intent to deceive).
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
How we write and review contentCriminal Law lawyers: ask a specialist about your case
Describe your situation briefly and we'll suggest a lawyer who specialises in this law
Criminal Law lawyers
Lawyers who handle this kind of case
Ibrahim Al Salem Law Firm
Active contributor
Dr. Ali Al-Rubaie Law Office and Ittihad Al-Asr Legal Company
Frequently asked questions about Article 41 of the Saudi Medical Devices Law
Is selling an adulterated medical device without the seller's knowledge a violation under item 2?
Item 2 requires, for selling, dispensing or possessing with intent to trade, that this be done with knowledge that the devices or supplies are adulterated.
Is attempting to bring in an unregistered device a violation?
Yes. Item 3 covers bringing in a device that is unregistered, adulterated or without a marketing authorization, or attempting to.
Is false advertising of a medical device a violation?
Yes. Item 5 treats as a violator anyone who uses untrue information to promote, on the device or in advertising for it.
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 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
- Article 46
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.
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 أ
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.