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MDD GN-06

GN-06

Guidance Notes GN-06 - Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices
Hong KongDepartment of HealthRegistration
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What this code is

GN-06 is the official MDD identifier for “Guidance Notes GN-06 - Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices”. GN-06 is the official identifier MDD uses for this instrument.

Instrument
GN-06
Full name
GN-06
Category
Registration
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Authority source
English
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16 articles · 1 language version
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Dates
Published
December 1, 2009
Effective
—
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English full text16 articles · English — GN-06:2026(E) (Ed. 1.0)Read HTML →
About this regulation

Guidance Notes GN-06 - Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices

Application guidance for listing Class B/C/D in vitro diagnostic medical devices (IVDMD), English expression GN-06:2026(E) (Ed. 1.0), edition 11 dated 31 July 2026 per the printed revision history. Covers IVDMD classification via TR-006, eligible applicants, application procedures with vetting timelines, appeal, and the clause-by-clause guide to application form MD102; edition 11 deleted the former Appendix I sample form. Ingested from the exact official PDF including the revision-history table; sections 1-11 carry stable anchors.

GN-06 is the official identifier MDD uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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