Share your views: Consultation on draft guidance for determining medical device application type
From: Health Canada
Current status: Closed
This consultation ran from September 11, 2023, and closed on November 10, 2023.
Health Canada asked for feedback on the draft Guidance for determining medical device application type. This guidance:
- explains the different application types
- will help manufacturers determine whether certain medical devices, including components and parts, should be combined and submitted as 1 device licence or authorization application
Who was the focus of this consultation
We sought comments from:
- medical device manufacturers
- other medical device stakeholders
Key items for discussion
We sought feedback on this draft guidance.
In particular, we were looking for feedback on the:
- overall clarity and content
- criteria for different application types
- examples provided
The input gathered through this process will be used to finalize the guidance document. This final document will replace the Guidance for the interpretation of sections 28 to 31: Licence application type.