mc_gov_sa · law · processed · 18 chunks
[Non-Text] وزاره التطاره Ministry of Commerce VISION لدا 23:30 حولكه العريل السعوزد KINGDOM OF SAUDI ARABIA Private Laboratories Law Article 1: In this Law, the following terms shall have the meanings assigned thereto: a. Competent Authority: Ministry of Commerce; Ministry of Health; Ministry of Environment, Water and Agriculture; Ministry of Industry and Mineral Resources; Ministry of Municipal, Rural Affairs and Housing; General Authority for Food and Drug; or other government agencies specified by the Implementing Regulations, as applicable. b. Center: Saudi Accreditation Center. c. Goods: Commercial goods produced locally or imported, whether in the form of materials, devices, tools, or any other form. d. Test: Any analysis, calibration, or examination which aims to determine the characteristics of performance, efficiency, effectiveness, or conformity. e. Laboratory: A place where goods are tested. Article 2: The competent minister may seek the assistance of licensed national private laboratories to test local and imported goods. Article 3: A license may be granted to a laboratory provided that the applicant commits to appoint qualified staff and provide necessary laboratory equipment and devices according to the volume and nature of the work, as determined by the Competent Authority and the Center. Article 4: The categories of laboratories and the conditions which must be met by each category shall be determined by the Implementing Regulations upon the Center's recommendation. Article 5: The procedures and period for license issuance shall be determined by the Implementing Regulations. Article 6: A holder of a license shall be given a period of not more than one year and six months from the date he obtains the license to complete the accreditation process; if he fails to do so prior to the lapse of the aforementioned period, the license shall be deemed revoked. Article 7: a. The Competent Authority shall issue the license to a private laboratory after paying the fee of five thousand riyals for the main laboratory and two thousand five hundred riyals for each branch. b. The license term shall be five years running from the date of the period set forth in Article (6) of the Law. The licensee may renew such license by filing an application to the Competent Authority at least three months prior to the license expiration date. Such renewal shall commence from the license expiration date. Article 8: The Competent Authority shall issue a list of goods which must undergo testing by a private laboratory 60 days prior to assigning such testing to the private laboratory and after announcing the same in the Official Gazette. The Zakat, Tax and Customs Authority shall be notified thereof. +966 11 294 4444 | Riyadh 11162 Kingdom of Saudi Arabia | المملكه العربيه السعوديه www.mci.gov.sa 1 [Non-Text] وزاره التجاره Ministry of Commerce VISION ده 23:30 العربيه العربيه السعوديه Kingdom of Saudi Arabia Article 9: The laboratory must comply with the following: a. Limiting testing to goods specified in the license. b. Complying with professional standards, maintaining work confidentiality, and ensuring equipment is in good condition. c. Maintaining records of test results for a period of not less than five years. d. Displaying the license and the Center's accreditation certificate in a conspicuous place near the laboratory's entrance. Any amendment thereto must be approved by the Competent Authority. e. Maintaining confidentiality when transporting samples and test results. Article 10: 1. The competent ministry's technicians shall collect and process samples according to approved standard specifications. 2. (a) The owner of imported goods may not dispose of said goods prior to final testing. (b) The owner of locally-produced goods may not dispose of said goods prior to their approval by the relevant agency. 3. The prepared sample shall be delivered to the private laboratory together with a document accurately describing the sample and indicating the required tests, in accordance with approved standard specifications. 4. The laboratory shall, within 15 days from the date of collecting the samples, return the results along with the remainder of the samples; if the samples are completely consumed, a proof thereof shall be presented to the providing party. The competent ministry shall be notified of the testing results within a period not exceeding 25 days from the date of collecting such samples. 5. Goods shall be tested at the expense of their owner. Article 11: Without prejudice to any harsher penalty provided for in any other law, any person who violates any of the provisions of this Law shall be subject to one or more of the following penalties: 1. Warning. 2. A fine of not less than five thousand riyals and not more than twenty thousand riyals. 3. Suspension of the license for a period of not less than 30 days and not more than 60 days. 4. Withdrawal of the license if the offense is repeated. Article 12: Delay fines shall be applied as follows: 1. One thousand riyals for every year of delay to be paid upon license renewal. Renewal shall commence from the license expiration date. 2. If the laboratory fails to submit the results within the period specified in Article 10(4), a fine equal to the costs of the test subject of the violation shall be imposed. Article 13: The supervision and inspection of laboratories and the detection of violations of the provisions of this Law and the regulations and decisions issued for its implementation shall be carried out by qualified officers. The Implementing Regulations shall specify: 1. the authority or authorities responsible for their appointment. +966 11 294 4444 | Riyadh 11162 لارياض Kingdom of Saudi Arabia | المملكه العربيه السعوديه @ SaudiMCI www.mci.gov.sa 2 [Non-Text] وزاره التجاره Ministry of Commerce VISION 230 دوله اعلوم السعود KINGDOM OF SAUDI ARABIA 2. the powers of officers authorized to access and inspect laboratories; detect violations; seize samples, documents, and devices subject of the violation; and conduct investigations, as well as specify the cases where the assistance of security agencies may be sought; and. 3. the authority which may grant access to laboratories for inspection. Monitoring, inspection, and detection officers shall be of good conduct and shall maintain confidentiality, and shall, upon carrying out their duties, present their credentials and indicate the purpose of their visit. Article 14: The Implementing Regulations shall determine investigation and prosecution procedures as well as the authority responsible therefor. Article 15: The Board of Grievances shall decide cases relating to violations of this Law and shall impose penalties. Article 16: The Minister of Commerce shall, in coordination with the Ministry of Interior; Ministry of Health; Ministry of Environment, Water and Agriculture; Ministry of Industry and Mineral Resources; Ministry of Municipal, Rural Affairs and Housing; General Authority for Food and Drug, issue the Implementing Regulations of this Law. Article 17: This Law shall be published in the Official Gazette and shall enter into force 180 days from the date of its publication. +966 11 294 4444 | Riyadh 11162 لارياض Kingdom of Saudi Arabia | المملكه العربيه السعوديه @ SaudiMCI www.mci.gov.sa 3