Article 34 of the Saudi Medical Devices Law
المادة 34 من نظام الأجهزة والمستلزمات الطبية
The article requires everyone subject to the Law to keep confidential any information he may obtain by virtue of his duties.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم كل من يخضع لأحكام النظام بالمحافظة على سرية المعلومات التي قد يحصل عليها بحكم مهمته.
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 34 explained in plain English
This article sets a duty of confidentiality. It requires everyone subject to the Law to keep confidential any information he may obtain by virtue of his duties.
Who is covered by the duty? The text is general: "everyone subject to the Law". It does not limit it to a particular category. It may include, for example, inspectors who see establishments' documents during inspection under Article 33, and establishments that see information through their activity.
What information is covered? Information the person obtains by virtue of his duties. The limit is the information's connection to the duty he performs. What a person knows outside the framework of his duties is not expressly addressed by the text.
Why is this provision important? Because the Law gives the Authority wide powers to request documents and information (Article 27), trace devices (Article 32) and inspect (Article 33). These powers allow access to commercial and technical secrets, so the duty of confidentiality reassures establishments that what they provide will not be used for any other purpose.
The article sets no specific penalty for breach of confidentiality. A person harmed by the disclosure of information obtained by someone by virtue of his duties may need to consult a lawyer who specializes in health and commercial regulations.
Practical example
During a visit to a factory in Riyadh, an inspector saw the details of a new device's production line. The article requires him to keep this information confidential because he obtained it by virtue of his duties.
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 34 of the Saudi Medical Devices Law
Are the Authority's inspectors bound to keep companies' information confidential?
The article requires everyone subject to the Law to keep confidential information obtained by virtue of his duties.
What kind of information is covered by confidentiality?
Information the person may obtain by virtue of his duties.
More articles on Inspecting Medical Establishments
- Article 33
The article gives the Authority power to inspect establishments and devices through inspectors who are judicial police officers, who may seize violating items, hold them, take samples and recommend destruction.
تتولى الهيئة التفتيش على المنشآت وعلى الأجهزة والمستلزمات الطبية؛ للتأكد من تطبيق أحكام النظام واللائحة واللوائح الفنية، وذلك من خلال مفتشين يعدون من رجال الضبط
- Article 35
The article requires the inspector to show his official card during inspection and seizure, and requires the establishment to enable him to do his work and not obstruct him.
على المفتش إبراز بطاقته الوظيفية عند تأديته لأعمال التفتيش والضبط، وعلى المنشأة تمكينه من أداء عمله، وعدم إعاقته.
- Article 36
The article allows the President, by decision, to grant the Authority's inspectors financial rewards for the work they perform.
يجوز -بقرار من الرئيس- منح مفتشي الهيئة مكافآت مالية نظير ما يقدمونه من أعمال.
- Article 37
The article allows the President, by decision, to grant a person other than an inspector who helps uncover a violation a reward of no more than 25% of the fine due.
يجوز -بقرار من الرئيس- منح مكافأة تشجيعية بنسبة لا تزيد على (25 %) من مقدار الغرامة المستحقة، لمن يساعد -من غير مفتشي الهيئة- في الكشف عن مخالفة لأحكام النظام و
- Article 38
The article tasks the Authority with setting the rules for granting inspectors' rewards and reporters' rewards, referred to in Articles 36 and 37, in agreement with the Ministry of Finance.
تضع الهيئة بالاتفاق مع وزارة المالية الضوابط المنظمة لمنح المكافآت المشار إليها في المادتين (السادسة والثلاثين) و(السابعة والثلاثين) من النظام.
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.