Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We currently sell a device that is listed as a Class II medical device in the US (water filter, non-dialysis).  However, after evaluating the classification in regards to Health Canada, it appears that the device would be considered non-medical.  Where/Who should I contact to obtain clarification regarding this?

I would recommend that you contact the Medical Devices Bureau at Health Canada directly for clarification. They may be able to point  you to a department within the bureau.

E-mail: mdb_enquiries@hc-sc.gc.ca

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Karen Zhou
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Original Message:
Sent: 25-Sep-2019 10:36
From: Anonymous Member
Subject: Classification of Medical Device (Health Canada)

This message was posted by a user wishing to remain anonymous

We currently sell a device that is listed as a Class II medical device in the US (water filter, non-dialysis).  However, after evaluating the classification in regards to Health Canada, it appears that the device would be considered non-medical.  Where/Who should I contact to obtain clarification regarding this?