MDD GN-02GN-02
GN-02 is the official MDD identifier for “Guidance Notes GN-02 - Guidance Notes for Listing Class II/III/IV General Medical Devices”. GN-02 is the official identifier MDD uses for this instrument.
- Instrument
- GN-02
- Full name
- GN-02
- Category
- Registration
- Authority source
- English
- Readable HTML
- 18 articles · 1 language version
- Published
- 2004
- Effective
- —
Open a language version
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-02 - Guidance Notes for Listing Class II/III/IV General Medical Devices
Application guidance for listing Class II/III/IV general medical devices, English expression GN-02:2026(E) (Ed. 1.0), edition 10 dated 31 July 2026 per the printed revision history. Covers classification via TR-003, eligible applicants, application procedures with vetting timelines, appeal, and the clause-by-clause guide to application form MD101; sections 12-13 reproduce the sample MDS-01/MDS-02 declarations. Ingested from the exact official PDF including the revision-history table; sections 1-13 carry stable anchors.
GN-02 is the official identifier MDD uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.