Summary Basis of Decision - - Health Canada
Summary Basis of Decision (SBD) for
Health Canada's Summary Basis of Decision (SBD) documents outline the scientific and regulatory considerations that factor into Health Canada regulatory decisions related to drugs and medical devices. SBDs are written in technical language for stakeholders interested in product-specific Health Canada decisions, and are a direct reflection of observations detailed within the evaluation reports. As such, SBDs are intended to complement and not duplicate information provided within the Operator's Manual.
Readers are encouraged to consult the 'Reader's Guide to the Summary Basis of Decision - Medical Devices' to assist with interpretation of terms and acronyms referred to herein. In addition, a brief overview of the medical device application review process is provided in the Fact Sheet entitled Safe Medical Devices in Canada'. This Fact Sheet describes the factors considered by Health Canada during the review and authorization process of a device licence application. Readers should also consult the 'Summary Basis of Decision (SBD Project: Phase II - Frequently Asked Questions' document. These documents are all available on the Health Canada website.
The SBD reflects the information available to Health Canada regulators at the time a decision has been rendered. Subsequent applications reviewed for additional uses will not be captured under Phase I of the SBD implementation strategy. For up-to-date information on a particular product, readers should refer to the most recent Operator's Manual for a product. For information related to Advisories, Warnings and Recalls as a result of adverse events (AE), interested parties are advised to access the Health Canada website.
For further information on a particular product, readers may also access websites of other regulatory jurisdictions, available under 'Related Links' on the Health Canada website. The information received in support of a Canadian device licence application may not be identical to that received by other jurisdictions.
Other Policies and Guidance
Readers should consult the Health Canada website for other medical device policies and guidance documents. In particular, readers may wish to refer to the 'Management of Applications for Medical Device Licences and Investigational Testing Authorizations Policy'.
1 Device and application information
Medical device group:
Application type and number:
Date license issued:
Device catalogue/Model number:
Refer to http://www.mdall.ca/
2 Response to conditions