Article 19 of the Saudi Fertility Units Law
المادة 19 من نظام وحدات الإخصاب والأجنة وعلاج العقم · الباب الثالث: شروط الترخيص لوحدات الإخصاب والأجنحة وعلاج العقم
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.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز تأسيس وحدة للإخصاب والأجنة وعلاج العقم ولا تشغيلها، إلا بعد الحصول على ترخيص الوزارة، بناء على توصية من لجنة الإشراف .
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 19 explained in plain English
This article lays down the condition of prior licensing for every fertility unit:
- What is prohibited: establishing the unit, and also operating it. The prohibition covers both stages, not operation alone.
- The condition: obtaining the Ministry's license, the Ministry being the Ministry of Health under Article 1.
- Basis of the license: a recommendation from the Supervisory Committee.
Under the definition in Article 1, a unit is any medical unit, government or private, that carries out fertilization, embryo and infertility treatment procedures, whether independent or part of a health institution. The licensing condition therefore covers government and private units, and independent units as well as those attached to a hospital or medical complex.
This provision works together with Article 18, which makes it a function of the Supervisory Committee to recommend granting the license and determine the level of activity after verifying that the licensing conditions are met, and to form technical committees to confirm this. Article 20 then sets out the three licensing levels: ovulation induction by injection, then artificial insemination, then in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and micromanipulation.
A person planning to establish a fertility unit should start by learning the licensing requirements, and may consult a lawyer who specializes in health regulations.
Practical example
An investor in Riyadh wants to set up a private infertility treatment center inside an existing medical complex. They may not establish or operate the unit until they obtain the Ministry of Health's license on the recommendation of the Supervisory Committee, even if the complex itself is licensed.
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 19 of the Saudi Fertility Units Law
Does an IVF center need a license?
Yes. A fertilization, embryo and infertility treatment unit may not be established or operated except after obtaining the Ministry's license on the recommendation of the Supervisory Committee.
Who grants the license of a fertility unit?
The Ministry of Health, on the recommendation of the Supervisory Committee.
Does a unit that is part of a hospital need a separate license?
The definition of a unit covers units that are independent or part of a health institution, and the article requires a license for every unit.
More articles on Licensing of Fertilization Units and Their Levels
- 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 21
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.
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 الع
- 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.