Article 33 of the Saudi Medical Devices Law
المادة 33 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 الجنائي يصدر بتسميتهم قرار من رئيس المجلس، ويكون لهم ما يأتي:
1- ضبط الأجهزة والمستلزمات الطبية المخالفة لأحكام النظام.
2- التعامل مع المضبوطات المخالفة، وذلك وفقًا لما يأتي:
أ- التحفظ عليها وعلى المستندات المتعلقة بها، عند الاقتضاء.
ب- أخذ العينات للتحليل.
ج- التوصية بإتلاف ما يثبت غشه، أو ضرره.
ويكون الإتلاف بعد صدور قرار به من الهيئة، وذلك وفقًا للأصول الفنية المتعارف عليها، وتتولى تنفيذه لجنة -أو أكثر- تكوَّن لهذا الغرض بقرار من رئيس المجلس. ويتحمل المخالف تكاليف عملية الإتلاف.
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 33 explained in plain English
This article governs the inspection carried out by the Authority of establishments and of medical devices and supplies, to confirm that the Law, the Regulations and the technical regulations are applied.
Who inspects? Inspectors who are considered judicial police officers, designated by a decision of the Chairman of the Board.
Their powers:
- Seizing medical devices and supplies that violate the Law's provisions.
- Dealing with seized items by:
- Holding them and the documents relating to them where necessary.
- Taking samples for analysis.
- Recommending the destruction of what is proven adulterated or harmful.
Destruction has safeguards: the inspector does not destroy anything himself, but only recommends. Destruction takes place:
- After a decision to do so is issued by the Authority.
- In accordance with recognized technical practice.
- Carried out by one or more committees formed by a decision of the Chairman of the Board.
And the violator bears the costs of destruction.
Article 35 complements this rule by requiring the inspector to show his official card, and requiring the establishment to allow him to do his work and not obstruct him. An establishment in which devices were seized, or for which destruction was recommended, may need to consult a lawyer who specializes in criminal cases and health regulations.
Practical example
During an inspection round at a warehouse in Dammam, an inspector suspected that a shipment of dressings was adulterated. He held it and its invoices and took samples for analysis. After the adulteration was proven he recommended destruction, the Authority issued its decision and a committee carried it out, and the warehouse owner bore the costs.
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 33 of the Saudi Medical Devices Law
Can a Food and Drug Authority inspector seize medical devices?
Yes. Inspectors may seize violating devices and supplies, and they are considered judicial police officers.
Who decides to destroy adulterated devices?
The inspector only recommends. Destruction takes place after a decision is issued by the Authority, and is carried out by a committee formed by decision of the Chairman of the Board.
Who bears the costs of destruction?
The article provides that the violator bears the costs of the destruction process.
More articles on Inspecting Medical Establishments
- Article 34
The article requires everyone subject to the Law to keep confidential any information he may obtain by virtue of his duties.
يلتزم كل من يخضع لأحكام النظام بالمحافظة على سرية المعلومات التي قد يحصل عليها بحكم مهمته.
- 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.