In force Last amended 6/4/1443 AH
Saudi Private Laboratories Law
نظام المختبرات الخاصة
Covers general provisions, licensing, hospitals, dispensaries, private and group clinics, medical laboratories, auxiliary medical service centers, penalties and final provisions.
- Articles
- 17
- In force
- 17
- Amended
- 8
- Issued
- 8/2/1423 AH
Issued by: مرسوم ملكي رقم م/3 بتاريخ 8 / 2 / 1423 هـ · قرار مجلس الوزراء رقم 29 بتاريخ 25 / 1 / 1423 هـ
Each article shows the official Arabic text, which is the only legally binding version, followed by our plain-English explanation.
Browse Private Laboratories Law by topic
Definitions of Private Laboratories and the Competent Authorities4 articlesPrivate Laboratory License5 articlesLicense Fees and Renewal2 articlesObligations of the Private Laboratory1 articleTaking Samples and Testing Goods2 articlesInspecting Laboratories2 articlesPenalties for Violating the Private Laboratories Law3 articles
Articles of the Saudi Private Laboratories Law
- Article 1The article defines the basic terms of the Private Laboratories Law: the competent authority, the Center, goods, testing and the laboratory.Amended M/31
- Article 2The article allows the competent Minister, by decision, to use qualified and licensed private national laboratories to test local and imported goods.
- Article 3The article requires, for licensing a laboratory, a commitment to provide qualified specialist staff and the necessary equipment and devices as determined by the competent authority and the Center.Amended M/31
- Article 4The article refers to the Implementing Regulations the determination of laboratory categories and the conditions for each category, on the recommendation of the Saudi Accreditation Center.Amended M/31
- Article 5The article refers to the Implementing Regulations the determination of the procedures for obtaining a private laboratory licence and the period needed to consider the application.
- Article 6The article gives the licensed laboratory a period of no more than a year and a half from the date of the licence to obtain accreditation from the Center, failing which the licence is considered cancelled.Amended M/31
- Article 7The article sets the private laboratory licence fee at SAR 5,000 for the main laboratory and SAR 2,500 for each branch, a licence period of five years, and how it is renewed.Amended M/31
- Article 8The article requires the competent authority to issue a decision on the goods to be tested by the private laboratory 60 days before assigning the task, after announcing them in the Official Gazette, with the Zakat, Tax and Customs Authority notified.Amended M/31
- Article 9The article sets five obligations on the private laboratory, including limiting itself to the licensed goods, honesty and confidentiality, keeping records for five years, and displaying the licence and accreditation.Amended M/31
- Article 10The article regulates drawing and preparing samples, the owner's undertaking not to dispose of the goods, delivering samples to the laboratory, the periods for returning results, and the owner of the goods bearing costs.
- Article 11The article sets the penalties for violating the Private Laboratories Law: a warning, a fine of SAR 5,000 to 20,000, suspension of the licence for 30 to 60 days, or its withdrawal in case of repetition.
- Article 12The article imposes a delay fine of SAR 1,000 for each year of delay in renewing the licence, and a fine equal to the testing costs if the laboratory is late in giving the result.
- Article 13The article entrusts monitoring laboratories, inspecting them and recording violations to specialized employees, refers their naming and powers to the Regulations, and obliges them to keep confidentiality and show their identity.
- Article 14The article refers to the Implementing Regulations the determination of the investigation and prosecution procedures for violations of the Private Laboratories Law and the body that carries them out.
- Article 15The article makes the Board of Grievances competent to adjudicate suits for violating the Private Laboratories Law and to impose penalties.
- Article 16The article assigns issuing the Implementing Regulations of the Private Laboratories Law to the Minister of Commerce in agreement with a number of ministries and the Food and Drug Authority.Amended M/31
- Article 17The article provides for publishing the Private Laboratories Law in the Official Gazette and applying it 180 days after the date of its publication.