SFDA MDS-G008MDS-G008
MDS-G008 is the official SFDA identifier for “Medical Device Classification Guidance”. MDS-G008 is the official identifier SFDA uses for this instrument.
- Instrument
- MDS-G008
- Full name
- MDS-G008
- Category
- Classification
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- 13 December 2022
- Effective
- 2022
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Medical Device Classification Guidance
MDS-G008 Version 2.0 (13 December 2022), 80 pages: the medical device classification guidance — the A-D risk class system, medical device definition and implementation rules (intended purpose, combination devices and accessories, body parts, multiple-rule devices, continuous use, direct diagnosis), the same rule set for IVD medical devices, and rule-by-rule explanations with practical examples. Saudi Arabia uses GHTF/IMDRF-aligned classification; the class determines the registration pathway.
MDS-G008 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.