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SFDA MDS-G-028-V1

MDS-G-028-V1/260503

Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application
Saudi ArabiaSaudi Food and Drug AuthorityRegistrationCurrentness under review
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Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

MDS-G-028-V1/260503 is the official SFDA identifier for “Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application”. MDS-G-028-V1/260503 is the official identifier SFDA uses for this instrument.

Instrument
MDS-G-028-V1
Full name
MDS-G-028-V1/260503
Category
Registration
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Source publication
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Dates
Published
May 5, 2026
Effective
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About this regulation

Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application

Complete official 17-page guidance, version 1.0 dated 3 May 2026; the official SFDA catalogue records publication on 5 May 2026. Preserves medical-device family, system, procedure-pack and IVD grouping criteria, limits, exceptions and definitions. Original page images govern; native text is a marked search layer. Product bundling within an MDMA application does not establish blanket permission to combine separate regulatory changes.

MDS-G-028-V1/260503 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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