What's new: Medical devices

For industry information about COVID-19, visit our COVID-19 medical devices section.

Files added to the web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks.

Consult the Drug and Health Product Register regularly for Regulatory Decision Summaries for medical devices.

Consult the Drug and Health Product Register regularly for Post-Licensing Activity Tables, which are added to Summary Basis of Decision documents for medical devices.

COVID-19

April 2021

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2021

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January

Regulatory innovation for health products [2021-01-29]

Join a WebEx tutorial on the 2021 annual licence review (ALR) application process [2021-01-22]

Consultation on Proposed Changes to the Medical Devices Directorate's Draft Guidance Document - List of Recognized Standards for Medical Devices [2021-01-15]

Foreign risk notification for medical devices guidance document: Background [2021-01-14]

Amendments to the Food and Drugs Act: Guide to new authorities [2021-01-14]

Incident reporting for medical devices: Guidance document [2021-01-14]

Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14]

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