Consultation on the draft Issue Identification Paper: Drug-device combination products

Drug-device combination products (DDCPs) are health products that combine one or more drug components with one or more medical device components into one single integrated product. Health Canada is updating its policy on DDCPs to provide more detail and clarity on the classification and regulation of these products. Participants in this consultation were asked to comment on an Issue Identification Paper, which was written to capture all of the outstanding issues with the current version of the policy.

Who was the focus of this consultation

Health Canada engaged with:

• manufacturers
• importers
• health system partners

Key questions for discussion

Ideas and inputs were sought on the following themes:

• classifying drug-device combination products
• assigning an appropriate single regulatory pathway
• establishing suitable authorization requirements

The input that was gathered through this process will help to create a shared understanding of the issues associated with the existing policy and will inform the policy work to support its update

What we heard

Final reports

What We Heard: Issue Identification Paper on Drug-Device Combination Products is available upon request.

Related information

• Policy on Drug/Medical Device Combination Products
• Policy on Drug/Medical Device Combination Products - Decisions

Contact us

Contact us by email: hc.policy.bureau.enquiries.sc@canada.ca