Article 20 of the Saudi Fertility Units Law
المادة 20 من نظام وحدات الإخصاب والأجنة وعلاج العقم · الباب الثالث: شروط الترخيص لوحدات الإخصاب والأجنحة وعلاج العقم
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 للمستويات الآتية وبالشروط التي تحددها اللائحة التنفيذية لهذا النظام :
المستوى الأول : علاج العقم بأدوية استحثاث الإباضة عن طريق الحقن.
المستوى الثاني : علاج العقم بالحقن الصناعي .
المستوى الثالث : علاج العقم بعمليات طفل الأنابيب والحقن المجهري والمنابلة الدقيقة .
وتحدد اللائحة التنفيذية لهذا النظام مؤهلات الأطباء المشرفين والأطباء الآخرين والفنيين العاملين في كل مستوى من هذه المستويات.
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 20 explained in plain English
This article divides fertility units into three levels according to the type of treatment they provide:
- First level: treating infertility with ovulation induction drugs given by injection.
- Second level: treating infertility by artificial insemination.
- Third level: treating infertility by in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and micromanipulation procedures.
These terms are defined in Article 1: ovulation induction is giving drugs to induce multiple ovulation; artificial insemination is preparing the husband's sperm and injecting it into the wife's uterus; IVF and ICSI rest on fertilization in the laboratory followed by returning the embryos; and micromanipulation means microscopic procedures on ova, sperm or embryos.
The article refers two matters to the Implementing Regulations:
- The conditions for licensing at each level.
- The qualifications of the supervising physicians, other physicians and technicians working at each level.
All of this is subject to the Law of Practicing the Profession of Human Medicine and Dentistry, the Private Health Institutions Law, and what has been issued under them.
This article follows Article 19, which requires the Ministry's license on the recommendation of the Supervisory Committee, and is followed by Article 21, which requires all the equipment and facilities necessary for each level, according to the specifications in the Regulations. A person who wants to know the right level for their unit may consult a lawyer who specializes in health regulations.
Practical example
An obstetrics and gynecology clinic in Medina wants to offer infertility treatment with ovulation-stimulating injections only. A first-level license is enough. If it later wants to perform ICSI, it will need a third-level license on the conditions 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 20 of the Saudi Fertility Units Law
What are the licensing levels for infertility treatment centers?
There are three: the first for treating infertility with ovulation induction drugs by injection, the second for artificial insemination, and the third for IVF, ICSI and micromanipulation.
Which level does an ICSI center need?
The third level, because it covers IVF, ICSI and micromanipulation procedures.
Who sets the qualifications of physicians at each level?
The Implementing Regulations of the Law set the qualifications of the supervising physicians, other physicians and technicians at each 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 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.