GN-16 R2
GN-16 R2 is the official HSA identifier for “Guidance on Essential Principles for Safety and Performance of Medical Devices (Revision 2, archived)”. GN-16 R2 is the official identifier HSA uses for this instrument.
- Instrument
- GN-16
- Full name
- GN-16 R2
- Category
- General
- Authority source
- English
- Readable HTML
- 104 articles · 1 language version
- Published
- June 1, 2018
- 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 on Essential Principles for Safety and Performance of Medical Devices (Revision 2, archived)
HSA GN-16 R2 (June 2018 PUB, archived 22 September 2022). Archived expression listed on the official HSA guidance-documents collection with an explicit ARCHIVED date; superseded by the current GN-16 row (sg-gn-16). Exact archived PDF ingested as sec-1 through sec-22-2-1.
GN-16 R2 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.