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SFDA MDS-G5

MDS-G5

Guidance on Requirements for Medical Device Listing and Marketing Authorization
Saudi ArabiaSaudi Food and Drug AuthorityRegistrationEffective 2020
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What this code is

MDS-G5 is the official SFDA identifier for “Guidance on Requirements for Medical Device Listing and Marketing Authorization”. MDS-G5 is the official identifier SFDA uses for this instrument.

Instrument
MDS-G5
Full name
MDS-G5
Category
Registration
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Authority source
English
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Dates
Published
22 June 2020
Effective
2020
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About this regulation

Guidance on Requirements for Medical Device Listing and Marketing Authorization

MDS-G5 Version 5.0 (22 June 2020), 149 pages: the comprehensive guidance on medical device listing and marketing authorization (MDMA) — general requirements, submission and post-submission processes, the required-documents matrix (declaration of compliance with GHTF founding-member regulations, essential principles, technical documentation), a flowchart, and Annexes 1-13, including the risk classification rules (Annex 5), clinical evaluation and PMCF (Annex 6), fees and review times (Annex 9), MDMA certificate content (Annex 10), and bundling criteria (Annex 12).

MDS-G5 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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