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HSA GN-12-2

GN-12-2

Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria
SingaporeHealth Sciences AuthorityRegistration
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What this code is

GN-12-2 is the official HSA identifier for “Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria”. GN-12-2 is the official identifier HSA uses for this instrument.

Instrument
GN-12-2
Full name
GN-12-2
Category
Registration
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Authority source
English
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11 articles · 1 language version
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Dates
Published
January 2022
Effective
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About this regulation

Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria

HSA GN-12-2 Revision 2 (January 2022). Companion to GN-12-1 covering device-specific grouping criteria for Class B dental devices, hearing aids, IHC IVDs, FISH probes, and IVF media. Ingested as sec-1 through sec-7 with the full device tables preserved in-section.

GN-12-2 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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