Article 40 of the Saudi Medical Devices Law
المادة 40 من نظام الأجهزة والمستلزمات الطبية
The article bars circulating medical devices and supplies if the Authority decides to withdraw them from the market or ban their circulation.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز تداول الأجهزة والمستلزمات الطبية إذا قررت الهيئة سحبها من السوق أو حظر تداولها.
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 40 explained in plain English
This article sets a clear rule: medical devices and supplies may not be circulated in two cases:
- If the Authority decides to withdraw them from the market.
- If the Authority decides to ban their circulation.
Under Article 1, circulation is making them available free of charge or for a fee, for distribution or for use. The ban therefore covers selling, free distribution and making them available for use.
Note that the ban rests on the Authority's decision: once the decision is issued, circulating these devices is barred, even if they previously held the marketing authorization.
The difference between this article and Article 31: Article 31 requires stopping circulation when a safety alert is issued until the Center issues its notice that the corrective action is complete, whereas this article concerns a withdrawal or ban decision by the Authority.
The article is linked to Article 39, which allows the Authority to take precautionary measures when it believes there is harm or a misleading claim, and to Article 41, which treats as a violator anyone who commits any violation of the Law's provisions.
Establishments should follow withdrawal and ban decisions and stop circulation immediately. An establishment that considers the decision incorrect may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
The Authority decided to withdraw a type of contact lens from the market. An optical shop in Buraidah still has stock of them. It may not sell or distribute them, even if they previously held the marketing authorization.
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 40 of the Saudi Medical Devices Law
Can I sell a medical device that the Authority decided to withdraw?
No. The article bars circulating medical devices and supplies if the Authority decides to withdraw them from the market or ban their circulation.
Can the withdrawn product be distributed free of charge?
Circulation includes making available free of charge or for a fee, so the ban covers free distribution.
More articles on Medical Device Incidents and Safety Alerts
- Article 28
The article requires the manufacturer, the authorized representative and the health care provider to report incidents involving their medical devices and supplies to the National Center for Device Reports.
على المصنع والممثل المعتمد ومقدم الرعاية الصحية الالتزام بإبلاغ المركز عن حوادث الأجهزة والمستلزمات الطبية التابعة لهم.
- Article 29
The article tasks the National Center for Device Reports with issuing the safety alert to warn users and health care providers of the risks of using medical devices and supplies.
يصدر المركز إنذار السلامة لتنبيه المستخدم ومقدم الرعاية الصحية بالأخطار الناتجة من استخدام الأجهزة والمستلزمات الطبية.
- Article 30
The article requires the manufacturer and the authorized representative to notify the Center of external safety alerts, risks affecting safety, and completion of the corrective action.
يلتزم المصنع والممثل المعتمد بإبلاغ المركز فيما يتصل بالأجهزة والمستلزمات الطبية التابعة لهما عن الآتي: 1- إنذارات السلامة الصادرة من الجهات الرقابية المماثلة خ
- Article 31
The article requires the establishment and the health care provider, when a safety alert is issued, to stop circulating the devices and supplies until the Center notifies them that the corrective action is complete.
على المنشأة ومقدم الرعاية الصحية في حال صدور إنذار السلامة إيقاف تداول الأجهزة والمستلزمات الطبية، حتى صدور إشعار من المركز بالانتهاء من الإجراء التصحيحي لإنذار
- Article 32
The article requires the establishment and the authorized representative to respond to the Authority's request to trace medical devices and supplies, and refers the procedures to the Regulations.
على المنشأة والممثل المعتمد الاستجابة لطلب الهيئة في اقتفاء أثر الأجهزة والمستلزمات الطبية. وتحدد اللائحة الإجراءات المتعلقة بذلك.
- Article 39
The article allows the Authority to take the necessary precautionary measures where it believes there is harm, a misleading claim, or an effect on the safety, security and adequacy of devices.
للهيئة اتخاذ التدابير الاحترازية اللازمة في حال الاعتقاد بوجود ضرر أو ادعاء مضلل أو تأثير على سلامة الأجهزة والمستلزمات الطبية ومأمونيتها وكفايتها، وفقًا لما تح
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.