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47494 records

Information needed for a submission to comply with the Regulations, licence holders and/or importers of Class II to IV medical …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Foreign risk notification medical devices guidance document What-when-and-how to submit information needed submission comply with the Regulations licence holders importers of Class-II-to-IV

Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML Unknown
Keywords: Guidance Document Health Canada Advertising Preclearance Agencies roles health product advertising

The objective of this guidance document is to assist industry and interested stakeholders (Market Authorization Holders (MAHs)) in developing a …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance Document submission Risk Management Plan additional risk-mitigation measures follow-up commitments

Health Canada recognizes that it is important for industry to disseminate non-promotional, accessible information on human and animal health products …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance advertising and other-activities health products disseminate non-promotional information accessible information human-and-animal health products health care professionals the general public promoting the sale a health product provide information

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance summary reports issue-related analyses safety and effectiveness medical devices medical device manufacturers Medical Devices Regulations new requirements monitoring of risks a product authorized for sale

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance summary reports issue-related analyses medical devices overview medical device manufacturers Medical Devices Regulations sections 25 39 and 61.4 to 61.6 new requirements monitoring benefits and risks ...

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance summary reports issue-related analyses medical devices medical device manufacturers Medical Devices Regulations new requirements monitoring of risks a product authorized for sale

Guidance to market authorization holders on issuing health product risk communications: Definitions.

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance market authorization holders health-product risk communications definitions

The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs).

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance market authorization holders health-product risk communications overview

The timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a …

Record Modified: Mar 30, 2024
Record Released: Mar 28, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Guidance market authorization holders health-product risk communications HPRC timeline develop-and-disseminate HPRC