Article 29 of the Saudi Medical Devices Law
المادة 29 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
يصدر المركز إنذار السلامة لتنبيه المستخدم ومقدم الرعاية الصحية بالأخطار الناتجة من استخدام الأجهزة والمستلزمات الطبية.
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 29 explained in plain English
This article identifies the tool used to warn people of risks: the safety alert, issued by the National Center for Medical Devices and Supplies Reports.
Under Article 1, a safety alert is a notice that explains:
- The risk associated with the medical device or supply.
- The corrective actions required to avoid the risk.
Those addressed by the alert under this article are:
- The user: by definition, whoever uses the device, whether a specialist, an ordinary person or a patient.
- The health care provider.
This article comes in a linked series: Article 28 requires the manufacturer, the authorized representative and the health care provider to report incidents to the Center, this article has the Center issue the alert, and then Article 30 requires the manufacturer and the authorized representative to notify the Center of matters including completion of the corrective action for a safety alert.
The benefit for an individual is that a safety alert may mean that a device he uses at home needs a particular action. A person harmed by a device that was the subject of an alert may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
The Center issued a safety alert about a type of home glucose meter found to give inaccurate readings, explaining the action required. Umm Mohammed in Tabuk, who uses this device, is one of the users the alert targets.
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 29 of the Saudi Medical Devices Law
Who issues the safety alert for medical devices?
The National Center for Medical Devices and Supplies Reports.
Who is the safety alert addressed to?
The user and the health care provider, to warn them of the risks arising from using medical devices and supplies.
What does a safety alert contain?
Under Article 1, it explains the risk associated with the device and the corrective actions required to avoid it.
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 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
- 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.