The Board of Directors of the Food and Drug Authority approved the approval of a table for classifying violations and the penalties prescribed for them, in accordance with the medical devices and supplies system and its implementing regulations, which included a fine of 30,000 riyals for the facility that deals with a device or medical requirement that a decision has been issued to withdraw or ban it from the market.
The table included the violation of advertising a medical device or equipment without obtaining the authority’s approval and a fine of 15,000 riyals. One or more penalties may also be imposed. Including closing the facility for a period not exceeding 180 days, suspending marketing permission for a period not exceeding 365 days, revoking permission to market medical devices and supplies subject to violation, preventing the violator from practicing any work related to medical devices and supplies for a period not exceeding 180 days, and revoking the license.
The table of violations included a fine of five thousand riyals when trading a medical device or equipment with an expired marketing authorization certificate, or without an import permit. This fine may rise to eight thousand in the event that trading takes place without obtaining a marketing authorization certificate.
Among the fines is the imposition of an amount of 35,000 riyals on the factory in the event that it manufactures or imports a high-risk medical device or requirement in violation of technical specifications and regulations. Fines for violating the circulation of a damaged or unusable medical device or supplies range from five thousand to 15 thousand riyals.
The Authority may impose other penalties; Including closing the facility for a period not exceeding 180 days, suspending marketing permission for a period not exceeding 365 days, revoking the marketing permission for medical devices and supplies subject to violation, preventing the violator from practicing any work related to medical devices and supplies for a period not exceeding 180 days, or revoking the license.
Financial fines for violations of licenses for establishments range between one thousand and 50 thousand riyals, and the financial fines start with penalties for licensing a certificate of marketing permission for medical devices and supplies from one thousand to 15 thousand, while the financial fine for violations and penalties for trading medical devices and supplies starts from five thousand riyals to 35 thousand riyals. While fines for violations of transportation, storage and workers range from 500 riyals to five thousand riyals, while fines are imposed from 500 riyals to 25 thousand riyals for violations related to control, and the authority may apply another penalty or more to the violators.
The fine for violations of examination of medical devices and supplies ranged from five thousand to 25 thousand riyals, and fines ranging from five thousand to 30 thousand riyals were imposed in the event of violations related to conformity verification service providers, and the fine starts from one thousand riyals to five thousand for violations of service providers. Quality assurance, and fines for violations committed in consulting services facilities range from one thousand to 10 thousand, while fines for violations of clinical studies facilities range from three thousand to 15 thousand riyals.
Fines for violations of maintenance service providers ranged from 1,000 to 10,000 riyals, from 3,000 to 20,000 riyals for advertising violations, and from 2,000 to 30,000 riyals for general violations.
License violations
