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Article 14 of the Saudi Medical Devices Law

المادة 14 من نظام الأجهزة والمستلزمات الطبية

The article requires anyone who dispensed or sold an adulterated, unregistered or unauthorized medical device to notify the Authority as soon as he learns of it and to refund the buyer's price.

Official text (Arabic)

This article has not been amended since the law was issued.

على كل من صرف أو باع جهازًا أو مستلزمًا طبيًّا مغشوشًا، أو غير مسجل، أو غير حاصل على الإذن بالتسويق، إبلاغ الهيئة -فور علمه بذلك- بالمعلومات التي تتعلق بما صُرف أو بِيع وكميته، واسم من صُرِف أو بِيع له الجهاز أو المستلزم الطبي وعنوانه، ويلتزم بإعادة الثمن للمشتري.

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 14 explained in plain English

Practical example

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 14 of the Saudi Medical Devices Law

Am I entitled to a refund for an adulterated medical device?

Yes. The article requires anyone who sold an adulterated, unregistered or unauthorized device to refund the price to the buyer.

When must the seller notify the Authority?

As soon as he learns that the device is adulterated, unregistered or without a marketing authorization.

What information must be reported?

The information about what was dispensed or sold and its quantity, and the name and address of the person it was dispensed or sold to.

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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.