Article 9 of the Saudi Medical Devices Law
المادة 9 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 وفقًا لما تحدده اللائحة.
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 9 explained in plain English
This article gives special flexibility to innovative medical devices and supplies, which under Article 1 are devices with an innovative idea in technology, use or performance that have not previously been placed on the markets, domestically or abroad.
The general rule in Article 8 is that any device needs registration and a marketing authorization before it is circulated. This article allows the Authority to exempt the innovative device from some of the conditions and procedures required for the marketing authorization. Note the following:
- The exemption is discretionary for the Authority and is not an automatic right of the innovator.
- It is an exemption from some conditions and procedures, not a complete exemption from the marketing authorization.
- The exemption must not affect the device's safety and security when used.
- The Implementing Regulations determine the details.
The difference between this article and Article 8 is that the exemption in Article 8 relates to devices not used for commercial purposes and covers the marketing authorization requirement itself, whereas this article relates to the innovative device and eases some conditions and procedures. Entrepreneurs in medical technology may benefit from consulting a lawyer who specializes in health and commercial regulations.
Practical example
A start-up in Riyadh developed a new device for monitoring breathing during sleep that has never been placed on any market. It can apply to the Authority to consider exempting its device from some marketing authorization conditions, and the Authority may agree so long as safety is not affected, as the Regulations determine.
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 9 of the Saudi Medical Devices Law
What is an innovative medical device?
Under Article 1, it is a device or supply with an innovative idea in technology, use or performance that has not previously been placed on the markets, domestically or abroad.
Is an innovative device completely exempt from the marketing authorization?
No. The article allows exempting it from some conditions and procedures only, without affecting its safety and security.
Is the exemption an acquired right of the innovator?
The article makes it discretionary for the Authority, by saying "the Authority may exempt", as the Regulations determine.
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 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.
- Article 12
The article refers to the Regulations the conditions needed to issue the free sale certificate for medical devices and supplies.
تحدد اللائحة الشروط اللازمة لإصدار شهادة حرية البيع.
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.