MDD GN-08GN-08
GN-08 is the official MDD identifier for “Guidance Notes GN-08 - Guidance Notes for Listing of Local Manufacturers of Medical Devices”. GN-08 is the official identifier MDD uses for this instrument.
- Instrument
- GN-08
- Full name
- GN-08
- Category
- Registration
- Authority source
- English
- Readable HTML
- 11 articles · 1 language version
- Published
- March 23, 2007
- 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-08 - Guidance Notes for Listing of Local Manufacturers of Medical Devices
Listing guidance for local manufacturers of medical devices under the MDACS, English expression GN-08:2026(E), edition 6 dated 1 September 2026 per the printed revision history. Covers local-manufacturer status with business registration, an ISO 13485 (or equivalent) quality management system certified by a recognized or GACI-accredited body covering the whole Listed Scope of Manufacture, device-list reporting at 12-month intervals, advertising and record/inspection duties, MDIS application processing within 12 weeks, five-year listing validity with renewal 12 weeks to 1 year before expiry, delisting grounds, appeal within 14 working days, and the Prevention of Bribery Ordinance. Unlike GN-00..GN-10 this document prints unnumbered section headings: the 11 table-of-contents sections (Introduction through References) carry stable sec-1..sec-11 anchors, while the printed clause numbers cited in its revision history (e.g. clause 4.1.3) are not part of the PDF text layer, so sub-clauses are not separately anchored.
GN-08 is the official identifier MDD uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.