Article 32 of the Saudi Medical Devices Law
المادة 32 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المنشأة والممثل المعتمد الاستجابة لطلب الهيئة في اقتفاء أثر الأجهزة والمستلزمات الطبية. وتحدد اللائحة الإجراءات المتعلقة بذلك.
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 32 explained in plain English
This article concerns tracing medical devices and supplies, meaning following them to know their source, their path and where they ended up.
Those addressed:
- The establishment: any legal entity that carries out an activity relating to medical devices and supplies.
- The authorized representative: the legal person authorized by the foreign manufacturer.
The obligation: to respond to the Authority's request to trace. The article rests on the Authority taking the initiative to make the request, after which comes the duty of the establishment and the representative to respond.
As for the procedures relating to this, such as how the request is made, the period for responding and the data required, the article refers them to the Regulations. No particular periods or forms should therefore be assumed without consulting them.
The importance of tracing is clear when there is a risk: if a safety alert is issued or a device is found to be adulterated, the Authority needs to know who received those devices. The article is linked to Article 27, which requires the establishment and the authorized representative to provide the Authority with every document or piece of information it requests, and to Article 31 on stopping circulation when an alert is issued.
To make responding easier, establishments need to keep organized import and distribution records. To learn the Regulations' requirements, you can consult a lawyer who specializes in health and commercial regulations.
Practical example
The Authority asked a distributor in Jeddah to trace a batch of medical catheters to find out which hospitals received them. The distributor must respond to the request under the procedures the Regulations set.
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 32 of the Saudi Medical Devices Law
Must a distributor respond to the Authority's request to trace devices?
Yes. The article requires the establishment and the authorized representative to respond to the Authority's request to trace medical devices and supplies.
Where do I find the tracing procedures?
The article refers the determination of these procedures to the Implementing Regulations.
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 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.