Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I have Drug/Medical device combination question for Health Canada.  The drug is providing the therapy with the device simply being the delivery mechanism of the IP.  In this case a CTA is required, however the device is not approved for marketing in Canada.  Which module of the CTA should the medical device documents be placed?

Thank you for your help and assistance.

Kind regards,

Anon,

Is the drug pre-filled into the device, or is the device being supplied physically separate from the drug? In the case of a pre-filled situation this is straightforward (only drug CTA required), however if you are supply a physically-separate device that is not licensed in Canada with the drug it is a more complex situation (and may require contacting Health Canada directly for a clear answer).

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Jonathan Amaya-Hodges
Sr. Principal Consultant
jamaya-hodges@suttonscreek.com
Suttons Creek, Inc.
United States
https://suttonscreek.com/
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Original Message:
Sent: 16-Nov-2021 15:57
From: Anonymous Member
Subject: Health Canada Drug/Device Combination help

This message was posted by a user wishing to remain anonymous

Hi all,

I have Drug/Medical device combination question for Health Canada.  The drug is providing the therapy with the device simply being the delivery mechanism of the IP.  In this case a CTA is required, however the device is not approved for marketing in Canada.  Which module of the CTA should the medical device documents be placed?

Thank you for your help and assistance.

Kind regards,