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An official government website affiliated with the Government of the Kingdom of Saudi Arabia.
icon Thu 25 Jun 2026
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Official Saudi government website domains end with gov.sa

All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

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Government websites use the protocol. HTTPS for encryption and security.

All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.

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Registered with the Digital Government Authority under number:
20250831619
Suggestions

Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?

Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?

icon 2024-02-20

Yes, based on bundling/grouping criteria on guidance MDS-G7:

https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf