Article 39 of the Saudi Medical Devices Law
المادة 39 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
للهيئة اتخاذ التدابير الاحترازية اللازمة في حال الاعتقاد بوجود ضرر أو ادعاء مضلل أو تأثير على سلامة الأجهزة والمستلزمات الطبية ومأمونيتها وكفايتها، وفقًا لما تحدده اللائحة.
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 39 explained in plain English
This article gives the Authority a preventive power to act before a violation is conclusively proven. It may take the necessary precautionary measures in three cases:
- A belief that there is harm.
- A misleading claim, such as incorrect information about a device's capabilities.
- An effect on the safety, security and adequacy of medical devices and supplies.
The standard here is "belief" that this exists. The text does not require that harm has been established with certainty. This is understandable in the health field, where waiting until harm is proven can be costly to people's health.
What are these measures? The article does not list them. It provides that they are as the Regulations determine. No particular measures should therefore be assumed without consulting them.
This article is linked to other provisions: Article 40 bars circulating devices that the Authority decides to withdraw from the market or ban from circulation, and Article 43 allows the Authority, when necessary, to take what precautionary measures it sees fit in the context of imposing penalties.
An establishment that is subject to a precautionary measure and considers it unjustified may need to consult a lawyer who specializes in health and commercial regulations to learn the available means of objection.
Practical example
Reports reached the Authority that a type of thermometer is being promoted with capabilities it does not have. The Authority may take precautionary measures as the Regulations determine, without waiting for a full investigation to finish, because the text is satisfied with a belief that a misleading claim exists.
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 39 of the Saudi Medical Devices Law
When does the Authority take precautionary measures?
When it believes there is harm, a misleading claim, or an effect on the safety, security and adequacy of devices.
Must harm be proven before measures are taken?
The text is satisfied with a belief that there is harm, a misleading claim or an effect on safety.
What are the precautionary measures?
The article does not list them, and refers to what the Regulations determine.
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 40
The article bars circulating medical devices and supplies if the Authority decides to withdraw them from the market or ban their circulation.
لا يجوز تداول الأجهزة والمستلزمات الطبية إذا قررت الهيئة سحبها من السوق أو حظر تداولها.
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.