Article 30 of the Saudi Medical Devices Law
المادة 30 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم المصنع والممثل المعتمد بإبلاغ المركز فيما يتصل بالأجهزة والمستلزمات الطبية التابعة لهما عن الآتي:
1- إنذارات السلامة الصادرة من الجهات الرقابية المماثلة خارج المملكة.
2- الأخطار التي تؤثر في مأمونية الجهاز أو المستلزم الطبي.
3- الانتهاء من الإجراء التصحيحي لإنذار السلامة.
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 30 explained in plain English
This article requires the manufacturer and the authorized representative to notify the Center of three matters relating to their medical devices and supplies:
- Safety alerts issued by similar regulators outside the Kingdom: if a regulator in another country issues an alert about a device that is circulated in the Kingdom, the Center must be notified.
- Risks that affect the safety of the medical device or supply.
- Completion of the corrective action for a safety alert: under Article 1, an action taken by the manufacturer to limit or reduce the risks that affect the device's safety.
The difference between this article and Article 28 is that Article 28 requires three parties, including the health care provider, to report incidents, whereas this article concerns the manufacturer and the authorized representative only, and relates to external alerts, risks and corrective actions.
The third item has practical importance: Article 31 requires the establishment and the health care provider, when a safety alert is issued, to stop circulating the devices until a notice is issued by the Center that the corrective action has been completed.
Manufacturers and their representatives need a mechanism to follow external alerts. To ask about obligations in a specific case, you can consult a lawyer who specializes in health and commercial regulations.
Practical example
A European regulator issued a safety alert about a type of heart valve. The company in Riyadh that is the manufacturer's authorized representative must notify the Center of this alert, and then notify it again when the corrective action is completed.
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 30 of the Saudi Medical Devices Law
Must a safety alert issued outside the Kingdom be reported?
Yes. The article requires the manufacturer and the authorized representative to notify the Center of safety alerts issued by similar regulators outside the Kingdom.
What is the corrective action for a safety alert?
Under Article 1, an action taken by the manufacturer to limit or reduce the risks that affect the safety of the medical device or supply.
Is a hospital bound by this article?
This article concerns the manufacturer and the authorized representative. The health care provider's obligation to report incidents is governed by Article 28.
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 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.