MDD GN-10GN-10
GN-10 is the official MDD identifier for “Guidance Notes GN-10 - Guidance Notes for Changes of Listed Medical Devices”. GN-10 is the official identifier MDD uses for this instrument.
- Instrument
- GN-10
- Full name
- GN-10
- Category
- Registration
- Authority source
- English
- Readable HTML
- 31 articles · 1 language version
- Published
- November 30, 2023
- Effective
- —
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guidance Notes GN-10 - Guidance Notes for Changes of Listed Medical Devices
Change-control guidance for listed medical devices under the MDACS, English expression GN-10:2026(E), edition 3 dated 26 June 2026 per the printed revision history. Covers the classification of changes by flowchart, notification and approval routes with processing timelines, changes not requiring reporting to the MDD, withdrawal of listing, appeal, and the Prevention of Bribery Ordinance clause; Appendix I carries the change flowcharts and Appendix II the documents required for a change application. Ingested from the exact official PDF including the revision-history table; sections 1-13 (12-13 being the appendices) carry stable anchors.
GN-10 is the official identifier MDD uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.