Draft guidance on managing applications for medical device licences: Closed consultation

From: Health Canada

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Health Canada sought feedback on the draft guidance document.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Draft guidance on managing applications for medical device licences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