Article 35 of the Saudi Medical Devices Law
المادة 35 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المفتش إبراز بطاقته الوظيفية عند تأديته لأعمال التفتيش والضبط، وعلى المنشأة تمكينه من أداء عمله، وعدم إعاقته.
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 35 explained in plain English
This article sets reciprocal obligations during inspection:
On the inspector: to show his official card when carrying out inspection and seizure work. This is a safeguard for the establishment, since it has the right to verify that the person inspecting it is in fact an inspector.
On the establishment:
- To enable the inspector to do his work.
- Not to obstruct him.
The article complements Article 33, which gives inspectors, who are considered judicial police officers, the powers to seize violating devices, hold them and their documents, take samples and recommend destruction. Article 35 ensures that these powers are exercised in an orderly way: the inspector identifies himself, and the establishment cooperates.
The practical effect: when an inspection visit takes place, the establishment does well to ask to see the official card, and then cooperate in enabling the inspector to do his work. Obstructing him is a breach of an obligation the article states, and may fall within the Law's violations under Article 41, which treats as a violator anyone who commits any other violation of its provisions.
The article does not detail what counts as obstruction. An establishment that objects to the way an inspection is carried out can consult a lawyer who specializes in health and commercial regulations.
Practical example
A person arrives at a clinic in Taif saying he is an inspector from the Authority. The clinic manager has the right to ask to see his official card, and after verifying it must enable him to inspect and not obstruct him.
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 contentCriminal Law lawyers: ask a specialist about your case
Describe your situation briefly and we'll suggest a lawyer who specialises in this law
Criminal 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 35 of the Saudi Medical Devices Law
Must an Authority inspector show his card?
Yes. The article requires him to show his official card when carrying out inspection and seizure work.
What is the establishment's duty during inspection?
To enable the inspector to do his work and not obstruct him.
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 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 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.