Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2023-12-24
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) (English, HTML) HTML
- Notice: Publication of the Guidance Document - Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) (French, HTML) HTML