Article 12 of the Saudi Medical Devices Law
المادة 12 من نظام الأجهزة والمستلزمات الطبية
The article refers to the Regulations the conditions needed to issue the free sale certificate for medical devices and supplies.
Official text (Arabic)
This article has not been amended since the law was issued.
تحدد اللائحة الشروط اللازمة لإصدار شهادة حرية البيع.
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 12 explained in plain English
This article concerns a document that manufacturers need for exporting: the free sale certificate. Under Article 1, it is a document the Authority issues to the manufacturer stating two things:
- That the manufacturer is registered in the Kingdom.
- That the medical devices and supplies to be exported have obtained the marketing authorization.
The practical benefit of this certificate is that it shows bodies abroad that the product is allowed to be circulated in the Kingdom. A manufacturer often needs such a document to market its products abroad.
But this article does not itself set the conditions for issuing the certificate. It refers their determination to the Implementing Regulations. A manufacturer that wants to export should therefore consult the Regulations to learn the required conditions and documents.
The definition makes clear that obtaining the certificate is tied to other obligations in the Law: registering the manufacturer and licensing it under Article 6, and registering the devices and their obtaining the marketing authorization under Article 8. A manufacturer preparing to export can consult a lawyer who specializes in health and commercial regulations.
Practical example
A factory in the Dammam industrial city produces medical syringes and wants to export them. It needs the free sale certificate from the Authority, which states that it is registered in the Kingdom and that the syringes have obtained the marketing authorization, and it consults the Regulations to learn the conditions for its issue.
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
How we write and review contentCommercial & Corporate Law lawyers: ask a specialist about your case
Describe your situation briefly and we'll suggest a lawyer who specialises in this law
Commercial & Corporate Law lawyers
Lawyers who handle this kind of case
Ibrahim Al Salem Law Firm
Active contributor
Dr. Ali Al-Rubaie Law Office and Ittihad Al-Asr Legal Company
Frequently asked questions about Article 12 of the Saudi Medical Devices Law
What is a free sale certificate?
Under the definition in Article 1, it is a document the Authority issues to the manufacturer stating that it is registered in the Kingdom and that the devices to be exported have obtained the marketing authorization.
Where do I find the conditions for obtaining a free sale certificate?
Article 12 refers the determination of these conditions to the Implementing Regulations.
More articles on Marketing Authorization for Medical Devices
- Article 8
The article bars circulating any medical device or supply before registration and marketing authorization, and allows the Authority to exempt some of them on conditions under rules approved by the Board.
لا يجوز تداول أي جهاز أو مستلزم طبي إلَّا بعد التسجيل، والحصول على الإذن بالتسويق. وللهيئة استثناء بعض الأجهزة والمستلزمات الطبية من شرط الحصول على الإذن بالتسو
- Article 9
The article allows the Authority to exempt an innovative medical device or supply from some marketing authorization conditions and procedures without affecting its safety and security.
للهيئة استثناء الجهاز أو المستلزم الطبي المبتكر من بعض الشروط والإجراءات اللازمة للحصول على الإذن بالتسويق؛ بما لا يؤثر في مأمونيته وسلامته عند استخدامه، وذلك و
- Article 10
The article refers to the Regulations the conditions and procedures for registration, issuing the marketing authorization, and for the license and its renewal, amendment, transfer and cancellation.
تحدد اللائحة الشروط والإجراءات اللازمة للتسجيل، وإصدار الإذن بالتسويق، والحصول على الترخيص وتجديده وتعديله ونقله وإلغائه.
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.