Article 42 of the Saudi Medical Devices Law

This article sets two levels of penalties:

First level (paragraph 1): for any violation of the Law or the Regulations, without prejudice to any heavier penalty in another law, one or more of the following are imposed:

• (a) A fine of no more than SAR 5,000,000.
• (b) Temporary closure of the establishment for a period not exceeding 180 days.
• (c) Suspension of the marketing authorization for the devices subject to the violation for a period not exceeding one year.
• (d) Cancellation of the marketing authorization for the devices subject to the violation.
• (e) Barring the violator from practicing any activity relating to devices for a period not exceeding 180 days.
• (f) Cancellation of the license.

Penalties (a), (b), (c) and (e) may be doubled in cases of repetition, and a violation is considered repeated if committed within one year of the date the first violation was committed.

Second level (paragraph 2): for the acts in items 1, 2, 3, 7 and 8 of Article 41, which are adulterating a device or attempting to, selling, dispensing or possessing adulterated items with intent to trade and with knowledge, bringing in unregistered, adulterated or unauthorized items or attempting to, bringing in packaging or wrappers with intent to deceive or attempting to, and making, printing, possessing, selling or displaying them with intent to deceive:

• Imprisonment for no more than 10 years, or a fine of no more than SAR 10,000,000, or both.
• In addition, any of penalties (b), (c), (d), (e) and (f) may be imposed.
• And the penalty is doubled in case of repetition.

The difference between the two levels in doubling: in paragraph 1 doubling is permitted, while in paragraph 2 the text says "is doubled". The Authority imposes the paragraph 1 penalties under Article 43, and paragraph 2 violations are referred to the Public Prosecution under Article 45. A person facing these penalties needs to consult a lawyer who specializes in criminal cases and health regulations.