Article 28 of the Saudi Medical Devices Law
المادة 28 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المصنع والممثل المعتمد ومقدم الرعاية الصحية الالتزام بإبلاغ المركز عن حوادث الأجهزة والمستلزمات الطبية التابعة لهم.
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 28 explained in plain English
This article imposes a reporting obligation on three parties:
- The manufacturer.
- The authorized representative.
- The health care provider, government or private.
The report goes to the Center, which under Article 1 is the National Center for Medical Devices and Supplies Reports.
The subject of the report: incidents involving their medical devices and supplies. Under Article 1, an incident is any deficiency or change in the device's characteristics or performance that may cause, or contribute directly or indirectly to, the death or serious injury of the user.
The definition is important: an incident does not require that death or injury actually occurred. It is enough that the deficiency is one that may cause it. Indirect contribution is also included.
The purpose of reporting is to enable the Center to monitor risks, which may lead to a safety alert being issued to warn users under Article 29. This article sets no deadline or form for the report. A person harmed by a medical device incident who wants to know his rights can consult a lawyer who specializes in health and commercial regulations.
Practical example
At a hospital in Riyadh, staff noticed that an intravenous infusion pump was delivering higher doses than it was set to, which could expose patients to serious risk. The hospital must report to the National Center for Medical Devices and Supplies Reports, even if no patient has yet been injured.
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 28 of the Saudi Medical Devices Law
Who must report medical device incidents?
The manufacturer, the authorized representative and the health care provider, each regarding the devices that belong to them.
Must an incident be reported if no injury actually occurred?
Under Article 1, an incident includes a deficiency that may cause or contribute to death or serious injury, so the definition does not require that the injury actually occurred.
Who receives the report?
The National Center for Medical Devices and Supplies Reports.
More articles on Medical Device Incidents and Safety Alerts
- 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
- 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.