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SFDA MDS-G-012

MDS-G-012 V1/230926

Guidance for Medical Device Marketing Authorization — Substantial and Non-substantial Changes
Saudi ArabiaSaudi Food and Drug AuthorityRegistrationCurrentness under review
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-012 V1/230926 is the official SFDA identifier for “Guidance for Medical Device Marketing Authorization — Substantial and Non-substantial Changes”. MDS-G-012 V1/230926 is the official identifier SFDA uses for this instrument.

Instrument
MDS-G-012
Full name
MDS-G-012 V1/230926
Category
Registration
Source links
Source publication
Arabic
Linked source text; confirm the publisher, publication details and any later amendment or consolidated version.
Readable HTML
1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
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Effective
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Readable full text

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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Guidance for Medical Device Marketing Authorization — Substantial and Non-substantial Changes

Complete official Arabic G012 version 1.0, with printed issue date 26 September 2023. Source-bound visual transcription repairs omitted headings, contents and Arabic extraction artifacts on nine physical pages. Original figures remain authoritative for workflow arrows, table structure, logos and artwork. This September 2023 expression is distinct from the March 2023 English expression.

MDS-G-012 V1/230926 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.