Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device

From Health Canada

This guidance:

• helps manufacturers determine when a change made to a device is significant
• explains the concepts that manufacturers must apply when making this determination
• provides many examples to help delineate the types of changes that are significant

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 seek to engage with medical device stakeholders, including:

• manufacturers of Class II to IV medical devices
• regulatory representatives

Key questions for discussion

Health Canada invites you to provide feedback on the overall clarity and content of the draft guidance.

We also would like you to answer the following questions:

• Is the document clear and comprehensible? Is there a need to clarify any of the concepts or principles presented in the document?
• Are there any concepts or principles missing from the document? If yes, please identify and explain.
• Are there any types of changes that could be made to a medical device that are missing from the document? If so, what are the types of changes that could be made to a medical device that need to be discussed?

We will use the comments we receive to finalize the guidance document.

Related information

• Food and Drugs Act
• Medical Device Regulations

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: mddpolicy-politiquesdim@hc-sc.gc.ca