Health Canada HCHC Guidance — IVD
HC Guidance — IVD is the official HC identifier for “Guidance for the Labelling of In Vitro Diagnostic Devices”. HC Guidance — IVD is the official identifier HC uses for this instrument.
- Instrument
- HC
- Full name
- HC Guidance — IVD
- Category
- Labeling
- Authority source
- English
- Readable HTML
- 7 articles · 1 language version
- Published
- April 22, 2016
- 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 for the Labelling of In Vitro Diagnostic Devices
Complete Health Canada labelling guidance for in vitro diagnostic devices: label and package-insert requirements walked element-by-element through MDR section 21(1)(a)-(j) (name, manufacturer, identifier, directions for use, performance characteristics, storage), outer-container requirements, sections 22-24 including bilingual accommodation under section 23, special considerations for blood glucose monitoring systems, and labelling for IVDDs containing explosive or corrosive materials. Foreword document control: date 22 April 2016, replacing the 1998/06/16 draft guidance. Ingested from the exact official HTML with a foreword preamble and sec-1..sec-7 section anchors.
HC Guidance — IVD is the official identifier HC uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.