Article 43 of the Saudi Medical Devices Law

This article identifies who imposes the penalties and how they are imposed.

Scope: the penalties provided for in paragraph 1 of Article 42, which are a fine of no more than SAR 5 million, temporary closure for no more than 180 days, suspension of the marketing authorization for no more than a year, cancellation of the marketing authorization, barring from practicing the activity for no more than 180 days, and cancellation of the license. The paragraph 2 penalties, including imprisonment, are not within the Authority's jurisdiction under this article, and under Article 45 are referred to the Public Prosecution.

The instrument: a table issued by the Board that includes a classification of violations and the penalties specified for each.

Criteria of assessment that the table takes into account:

• The nature of the activity.
• The violation committed and its seriousness in each case separately.
• Aggravating and mitigating circumstances.

Approval: penalties are approved by decision of the President or his delegate.

Precautionary measures: in all cases, the Authority may, when necessary, take what precautionary measures it sees fit.

The practical meaning is that a violating establishment is not punished arbitrarily, but under a prior table that takes account of the circumstances of each case. Someone against whom a penalty decision has been issued may file a grievance before the committee provided for in Article 44. It is advisable to consult a lawyer who specializes in health and commercial regulations when filing a grievance.