Article 31 of the Saudi Medical Devices Law
المادة 31 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 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 31 explained in plain English
This article sets what must be done in practice when a safety alert is issued about a medical device or supply.
Those addressed:
- The establishment: any legal entity that carries out an activity relating to medical devices and supplies, such as a distributor, a warehouse or a store.
- The health care provider: government and private hospitals and clinics.
The obligation: to stop circulating the medical devices and supplies covered by the alert. Under Article 1, circulation includes making them available free of charge or for a fee, for distribution or for use, so stopping covers selling, distributing and making them available for use.
Duration of the stop: until a notice is issued by the Center that the corrective action for the safety alert has been completed. The establishment does not decide for itself when to resume circulation, but waits for the Center's notice.
The article is linked to Article 30, which requires the manufacturer and the authorized representative to notify the Center of completion of the corrective action; that notification precedes the Center's notice, after which circulation resumes. It is also linked to Article 29, which tasks the Center with issuing the alert.
Establishments should follow safety alerts continuously. If in doubt about the scope of a particular alert, they can contact the Center or consult a lawyer who specializes in health and commercial regulations.
Practical example
A medical supplies warehouse in Riyadh holds stock of oxygen monitors that are the subject of a safety alert. It must stop distributing them to pharmacies immediately, and may not resume distribution until the Center issues a notice that the corrective action has been 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 31 of the Saudi Medical Devices Law
What must a hospital do when a safety alert is issued?
Stop circulating the devices or supplies covered until a notice is issued by the Center that the corrective action has been completed.
When can sale of the device resume after the alert?
After the Center issues a notice that the corrective action for the safety alert has been completed.
Does the stop cover free distribution?
Under Article 1, circulation includes making them available free of charge or for a fee, so the stop covers 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 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 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.