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Found 2972 records

Medical batteries are medical devices and are regulated under the Food and Drugs Act and Medical Devices Regulations. The Act …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical batteries medical devices Food-and-Drugs Act Medical Devices Regulations import advertising sale of medical-devices

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical device medical device reports medical device publications medical instruments treatment mitigation diagnosis prevention of a disease abnormal physical condition

Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical-device medical-device single-audit program MDSAP manufacturers medical-device licences medical-devices sold in-Canada higher quality standards

A growing number of Canadians are using medical test kits in their homes to diagnose or monitor certain health conditions. …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: medical test-kits home use diagnose certain health-conditions medical devices potential benefits present risks

This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice guidance document requirements recognition process medical-device single-audit program MDSAP auditing organizations medical-device stakeholders

This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice guidance post-drug identification-number DIN changes drugs regulated under-part-C

This report, which is tabled under section 20 of the Service Fees Act and section 4.2.8 of the Directive on …

Record Modified: Nov 12, 2023
Record Released: Nov 10, 2023
Publisher: Health Canada
Formats: HTML
Keywords: fees report Health Canada

Table of contents
A. Commitments and priorities overview
Mandate letters
2021 Speech from the throne – summary
Budget 2023 – …

Record Modified: Nov 9, 2023
Record Released: Nov 7, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Ministerial Briefing Material

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance …

Record Modified: Nov 2, 2023
Record Released: Oct 31, 2023
Publisher: Health Canada
Formats: HTML
Keywords: qualifying notice lumakras notice-of-compliance with conditions-qualifying notice NOC/c-QN

Q10: Pharmaceutical Quality System. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject …

Record Modified: Nov 2, 2023
Record Released: Oct 31, 2023
Publisher: Health Canada
Formats: HTML
Keywords: international-conference on harmonisation ICH ICH of technical-requirements registration of pharmaceuticals pharmaceuticals for human-use ICH guidance Q10 pharmaceutical quality system