Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs).
Why is Health Canada consulting on this policy?
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.
Who does Health Canada aim to engage with via the consultation?
Health Canada aims to engage with:
- manufacturers
- importers
- health system partners
What are the key questions concerning the consultation?
Health Canada is seeking input on the following themes:
- classifying drug-device combination products
- assigning an appropriate single regulatory pathway
- establishing suitable authorisation 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.
Where can you find the draft for consultation?
The Issue Identification Paper: Drug-Device Combination Products (DDCPs) Draft for Consultation is available here.
You can send your input to Health Canada by email: hc.policy.bureau.enquiries.sc@canada.ca.
What are the start and end dates for the consultation?
Start date: 10 May 2021
End date: 12 July 2021
Source: Health Canada website