SFDA MDS-REQ-001-V6MDS-REQ-001-V6/211219
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MDS-REQ-001-V6/211219 is the official SFDA identifier for “Medical Devices Marketing Authorization Requirements — Version 6.0 (2021)”. MDS-REQ-001-V6/211219 is the official identifier SFDA uses for this instrument.
- Instrument
- MDS-REQ-001-V6
- Full name
- MDS-REQ-001-V6/211219
- Category
- Registration
- Source publication
- English
- Readable HTML
- 1 language version
- Published
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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.
Medical Devices Marketing Authorization Requirements — Version 6.0 (2021)
Complete 109-page historical English MDS-REQ1 Version 6.0, including its original annexes. The cover’s 19 December 2021 is a version date. Original Annex 15 is retained as historical context: separately admitted MDS-G028 expressly replaces that annex on its physical page 17. No claim is made that all annexes remain current. SFDA directory and landing captures on 21 October 2026 still linked this V6 body; that dated observation does not establish perpetual legal currentness. Medical-device and IVD provisions retain their stated scope. Original page images govern; embedded native text is a qualified search layer. No new facts or question answers are proposed.
MDS-REQ-001-V6/211219 is the official identifier SFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.