Article 21 of the Saudi Fertility Units Law
المادة 21 من نظام وحدات الإخصاب والأجنة وعلاج العقم · الباب الثالث: شروط الترخيص لوحدات الإخصاب والأجنحة وعلاج العقم
The article requires every fertility unit to have all the equipment and facilities needed for each licensing level, according to the specifications set by the Implementing Regulations.
Official text (Arabic)
This article has not been amended since the law was issued.
يجب توافر جميع التجهيزات والمرافق اللازمة لكل مستوى بحسب المواصفات التي تحددها اللائحة التنفيذية لهذا النظام، وذلك في كل وحدة من وحدات الإخصاب والأجنة وعلاج العقم.
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 21 explained in plain English
This article deals with equipment and facilities in fertility units:
- What is required: all the necessary equipment and facilities must be available, so having only some of them is not enough.
- The standard: what is necessary for each level of licensing.
- The reference: the specifications set by the Implementing Regulations.
- The scope: every unit of fertilization, embryo and infertility treatment.
Linking equipment to the level means that what is required of a first-level unit differs from what is required of a third-level unit. Under Article 20, the levels are: the first for treating infertility with ovulation induction drugs by injection, the second for artificial insemination, and the third for IVF, ICSI and micromanipulation.
The article itself does not name any specific equipment; all the details are in the Implementing Regulations.
This article is followed by Article 22, which provides that a license granted for a given level includes the lower levels before it. A unit licensed for a higher level is therefore covered for the levels below it.
A person equipping a fertility unit who wants to confirm it meets the specifications may refer to the Regulations or consult a lawyer who specializes in health regulations.
Practical example
A fertility unit in Abha applies for a second-level license (artificial insemination). It must have all the equipment and facilities necessary for that level, according to the specifications the Implementing Regulations set.
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 21 of the Saudi Fertility Units Law
What equipment is required in an IVF center?
The article refers the specifications to the Implementing Regulations and requires all the equipment and facilities necessary for each level to be available.
Does the equipment differ according to the licensing level?
Yes. The article links the necessary equipment and facilities to each level.
Is it enough to have some of the equipment?
No. The article requires all the equipment and facilities necessary for the level.
More articles on Licensing of Fertilization Units and Their Levels
- Article 19
The article bars establishing or operating a fertilization, embryo and infertility treatment unit except after obtaining the Ministry's license on the recommendation of the Supervisory Committee.
لا يجوز تأسيس وحدة للإخصاب والأجنة وعلاج العقم ولا تشغيلها، إلا بعد الحصول على ترخيص الوزارة، بناء على توصية من لجنة الإشراف .
- Article 20
The article sets three licensing levels for fertility units: ovulation induction by injection, then artificial insemination, then IVF, ICSI and micromanipulation, and refers the conditions and qualifications to the Implementing Regulations.
مع مراعاة ما يقضي به نظام ممارسة مهنة الطب البشري وطب الأسنان ونظام المؤسسات الصحية الخاصة وما صدر بشأنهما، يرخص لوحدات الإخصاب والأجنة وعلاج العقم وفقًا للمستو
- Article 22
The article provides that a fertility unit's license for a given level includes the lower levels before it.
يشمل الترخيص الممنوح لوحدات الإخصاب والأجنة وعلاج العقم لمستوى معين ما قبله من مستويات أدنى.
- Article 23
The article obliges fertility units to announce the licensed level together with the unit's name on internal and external signs and in its printed materials.
على وحدات الإخصاب والأجنة وعلاج العقم إعلان المستوى المرخص به مقرونًا باسم الوحدة في اللوحات الداخلية والخارجية ومطبوعاتها.
- Article 24
The article bars licensing a fertilization, embryo and infertility treatment laboratory unless it is within a licensed fertility unit.
لا يجوز الترخيص لمعمل الإخصاب والأجنة وعلاج العقم إلا ضمن وحدة إخصاب مرخص لها.
- Article 25
The article restricts reproductive techniques requiring laparoscopy or general anesthesia to fertility units inside hospitals or units permitted to perform day surgery.
لا يسمح بإجراء تقنيات التناسل التي تتطلب تنظيرًا للبطن أو تخديرًا عامًّا إلا لوحدات إخصاب داخل مستشفى أو لوحدات لديها تصريح بجراحة اليوم الواحد.
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.