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SFDA MDS-G-011

MDS-G-011 V2/250707

Guidance on Manufacturing Paths of Medical Devices
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-011 V2/250707 is the official SFDA identifier for “Guidance on Manufacturing Paths of Medical Devices”. MDS-G-011 V2/250707 is the official identifier SFDA uses for this instrument.

Instrument
MDS-G-011
Full name
MDS-G-011 V2/250707
Category
Registration
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English
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About this regulation

Guidance on Manufacturing Paths of Medical Devices

Complete official English translated copy of MDS-G-011-V2/250707, version 2.0 with printed Version Date 7 July 2025; separate publication date not established. Scope covers design/manufacturing within KSA (including IVD definition), with overseas actor notes retained. Full manufacturing, branch/site and third-party contract paths remain distinct from a registered-office edit. All original tables, symbols and artwork retained.

MDS-G-011 V2/250707 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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