The Board of Directors of the Saudi Food and Drug Authority,
after perusal of article 43 of the Law of Medical Devices and Supplies, which stipulates that the authority shall impose the punishments stipulated in article 42(1) of the law, in accordance with a schedule issued by the board comprising a classification of the violations and the punishments specified for each of them,
after perusal of Board of Directors Decision 3-33-1443 dated 16 Ramadan 1443 [17 April 2022], approving the Schedule of Classification of Violations and Punishments Prescribed to Them in Accordance with the Law of Medical Devices and Supplies and Its Executive Regulation,
after perusal of Royal Order 32043 dated 5 Jumada Al-Awwal 1444 [29 November 2022], which directs a number of government entities—within the area of their mandates—and the Saudi Food and Drug Authority to review the laws, regulations, decisions, and their equivalent related to violations, punishments, fines, assessment and collection mechanisms, and objections, and to propose the necessary amendments to them,
after perusal of the royal directive in Telegram 11438 dated 17 Safar 1445 [2 September 2023], which directs all government entities to implement the principle of issuing a warning prior to a violation and to give establishments the opportunity to rectify the violation,
after perusal of Executive Committee Decision 8/TH/27 dated 29 Jumada Al-Awwal 1446 [1 December 2024], which recommends presenting the draft amendment to the Schedule of Classification of Violations and Punishments in Accordance with the Law of Medical Devices and Supplies and its executive regulation to the Board of Directors for approval in the attached form,
after perusal of the draft amendment to the Schedule of Classification of Violations and Punishments in Accordance with the Law of Medical Devices and Supplies and Its Executive Regulation,
and after perusal of the schedule of the most significant amendments to the schedule of classification of violations and punishments,
hereby decides
The amendment to the Schedule of Classification of Violations and Punishments in Accordance with the Law of Medical Devices and Supplies and Its Executive Regulation is hereby approved in the form attached.
May Allah provide success.
Issued on: 14 Jumada Al-Thani 1446
Corresponding to: 15 December 2024
Published in Umm Al-Qura 5166 issued on 23 June 2026.