Notice - Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)

June 12, 2015

Our file number: 15-104840-10

Re: Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)

Health Canada is pleased to announce the release of the final version of the guidance document, Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs). A draft version of this guidance document was first released in 1998. Comments received have been considered in the development of this final version.

This guidance document conforms to Good Guidance Practices (GGPs) and, in response to requests from stakeholders, has been revised to include up-to-date examples. It is intended to clarify the application of the risk classification rules set out in the Medical Devices Regulations for non-IVDDs.

For more information on this guidance document, please contact:

Device Licensing Services Division
Medical Devices Bureau
Health Products and Food Branch, Therapeutic Products Directorate
Health Canada
2934 Baseline Road
Address Locator: 3403A
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-7285
Email: devicelicensing-homologationinstruments@hc-sc.gc.ca