Share your views: Consultation on draft guidance for determining medical device application type

From: Health Canada

Health Canada wants your feedback on the draft Guidance for determining medical device application type.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

Join in: how to participate

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

Who is the focus of this consultation

We're seeking comments from:

• medical device manufacturers
• other medical device stakeholders

Key items for discussion

We're seeking your feedback on this draft guidance.

In particular, we would like 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.

Contact us

Email: mddpolicy-politiquesdim@hc-sc.gc.ca