Draft guidance on managing applications for medical device licences: Closed consultation
From: Health Canada
Current status: Closed
This consultation ran from February 20, 2025 to April 21, 2025.
Health Canada asked for feedback on the updated Guidance on the Management of Applications for Medical Device Licences. This document explains to medical device manufacturers how medical device licence applications submitted under the Medical Devices Regulations are managed.
Who was the focus of this consultation
We engaged with medical device stakeholders, including:
- medical device manufacturers
- regulatory affairs representatives in the field of medical devices
Key areas for discussion
Health Canada sought feedback on the draft guidance document. In particular, we were looking for comments on the:
- overall clarity and content
- revamped reconsideration process
The comments we received will help us finalize the guidance document, which will replace the current version.
Draft guidance on managing applications for medical device licences
Contact us
Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9
Email: meddevices-instrumentsmed@hc-sc.gc.ca