Share your views: Consultation on the draft guidance on managing applications for medical device licences

From: Health Canada

Health Canada has updated the 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.

Join in: how to participate

Send an email to meddevices-instrumentsmed@hc-sc.gc.ca with your ideas or comments to make yourself heard.

Who is the focus of this consultation

We seek to engage with medical device stakeholders, including:

• medical device manufacturers
• regulatory affairs representatives in the field of medical devices

Key areas for discussion

Health Canada invites you to provide feedback on the draft guidance document. In particular, we are looking for feedback on the:

• overall clarity and content
• revamped reconsideration process

We will consider the comments we receive when finalizing 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Draft guidance on managing applications for medical device licences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