Law of Medical Devices and Supplies
Art. 42Status unknownSaudi ArabiaRegulation
Issued by Ministry of Investment (misa.gov.sa)
1. Without prejudice to any harsher penalty provided for in any other law, any
person who commits any violation of this Law or the Regulations shall be
subject to one or more of the following penalties:
a) A fine not exceeding five million riyals.
b) Temporary closure of the establishment for a period not exceeding 180
days.
c) Suspension of the marketing authorization of medical devices and
supplies subject of the violation for a period not exceeding one year.
d) Revocation of the marketing authorization of medical devices and supplies
subject of the violation.
e) Preventing the violator from engaging in any activity related to medical
devices and supplies for a period not exceeding 180 days.
f) Revocation of the license.
g) The penalty imposed pursuant to sub-paragraphs (a), (b), (c), and (e) of
this paragraph may be doubled if the violation is repeated. A violation shall
be deemed a repeated violation if it is committed within one year from the
date the first violation is committed.
2. A person who commits any of the acts stipulated in Article 41(1, 2, 3, 7 and
8) of this Law shall be subject to imprisonment for a period not exceeding
ten years, a fine not exceeding ten million riyals, or both. In addition to said
penalties, the penalties stipulated in paragraph (1) (b, c, d, e, and f) of this
Article may be imposed. The penalty shall be doubled if the violation is
repeated.
The Arabic text is the legally binding version. The English translation is provided for guidance only.
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