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. As the first step, an Issue Identification Paper has been drafted to capture the outstanding issues with the current version of the policy.

Join in: how to participate

Review the issue identification paper:

Drug-Device Combination Products (DDCPs) Issue Identification Paper

Send us your input by email:

hc.policy.bureau.enquiries.sc@canada.ca

Who is the focus of this consultation

Health Canada aims to engage with:

• manufacturers
• importers
• health system partners

Key questions for discussion

Through this consultation, Health Canada wants to make sure that key stakeholders:

• are aware of this initiative to update the policy on drug-device combination products
• have the opportunity to identify any concerns they have with the current version of the policy

We are seeking your input on the following themes:

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

The information gathered from 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.

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