Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Group, 

I have a question regarding MDL for Canada. 

If a device is licensed class II for my company but we are only doing the labeling, repackaging and distribution to Canada. Also the supplier has the device licensed as class II. In this case - who takes upon the responsibilities for PMS - summary report, other field actions, reporting and so forth.

Any guidance is appreciated. 

Thanks!

Hello Anon

From your brief description I'm not sure if you have a private labeling agreement or a distribution agreement. Health Canada has some precise definitions of the different possible roles, and different responsibilities assigned to each.

See the definitions in this guidance:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html

And a bit about private labeling here:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/private-label-medical-devices-questions-answers.html

Then see the guidances on reporting, recalls, and so forth.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 11-Aug-2022 12:01
From: Anonymous Member
Subject: Canada MDL responsibility

This message was posted by a user wishing to remain anonymous

Hello Group,

I have a question regarding MDL for Canada.

If a device is licensed class II for my company but we are only doing the labeling, repackaging and distribution to Canada. Also the supplier has the device licensed as class II. In this case - who takes upon the responsibilities for PMS - summary report, other field actions, reporting and so forth.

Any guidance is appreciated.

Thanks!

Hello,

Agree with Anne is not clear who is defined as the (legal) Manufacturer for the device.  Ultimately, the Manufacturer has the responsibilities for post market activities, though this may also be managed or contributed by a Distributor or Private Labeller.  It sounds like the 'supplier' which is the original manufacturer would be the Manufacturer and ultimately responsible for post market activities including reporting.  Then as a distributor the responsibility would be to provide complaint information to the Manufacturer.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Aug-2022 21:28
From: Anne LeBlanc
Subject: Canada MDL responsibility

Hello Anon

From your brief description I'm not sure if you have a private labeling agreement or a distribution agreement. Health Canada has some precise definitions of the different possible roles, and different responsibilities assigned to each.

See the definitions in this guidance:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html

And a bit about private labeling here:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/private-label-medical-devices-questions-answers.html

Then see the guidances on reporting, recalls, and so forth.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 11-Aug-2022 12:01
From: Anonymous Member
Subject: Canada MDL responsibility

This message was posted by a user wishing to remain anonymous

Hello Group,

I have a question regarding MDL for Canada.

If a device is licensed class II for my company but we are only doing the labeling, repackaging and distribution to Canada. Also the supplier has the device licensed as class II. In this case - who takes upon the responsibilities for PMS - summary report, other field actions, reporting and so forth.

Any guidance is appreciated.

Thanks!

This is where a written supplier agreement would be helpful.

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 12-Aug-2022 04:18
From: Richard Vincins
Subject: Canada MDL responsibility

Hello,

Agree with Anne is not clear who is defined as the (legal) Manufacturer for the device.  Ultimately, the Manufacturer has the responsibilities for post market activities, though this may also be managed or contributed by a Distributor or Private Labeller.  It sounds like the 'supplier' which is the original manufacturer would be the Manufacturer and ultimately responsible for post market activities including reporting.  Then as a distributor the responsibility would be to provide complaint information to the Manufacturer.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Aug-2022 21:28
From: Anne LeBlanc
Subject: Canada MDL responsibility

Hello Anon

From your brief description I'm not sure if you have a private labeling agreement or a distribution agreement. Health Canada has some precise definitions of the different possible roles, and different responsibilities assigned to each.

See the definitions in this guidance:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html

And a bit about private labeling here:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/private-label-medical-devices-questions-answers.html

Then see the guidances on reporting, recalls, and so forth.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 11-Aug-2022 12:01
From: Anonymous Member
Subject: Canada MDL responsibility

This message was posted by a user wishing to remain anonymous

Hello Group,

I have a question regarding MDL for Canada.

If a device is licensed class II for my company but we are only doing the labeling, repackaging and distribution to Canada. Also the supplier has the device licensed as class II. In this case - who takes upon the responsibilities for PMS - summary report, other field actions, reporting and so forth.

Any guidance is appreciated.

Thanks!

This message was posted by a user wishing to remain anonymous

Hello Anon, 

If I understand your question correctly, you will need to determine who the legal manufacturer is.  It's the legal manufacturer's responsibility to conduct postmarketing activities (e.g., filing of the summary reports etc); however, this may be delegated to an importer through written authorization.
Original Message:
Sent: 11-Aug-2022 12:01
From: Anonymous Member
Subject: Canada MDL responsibility

This message was posted by a user wishing to remain anonymous

Hello Group,

I have a question regarding MDL for Canada.

If a device is licensed class II for my company but we are only doing the labeling, repackaging and distribution to Canada. Also the supplier has the device licensed as class II. In this case - who takes upon the responsibilities for PMS - summary report, other field actions, reporting and so forth.

Any guidance is appreciated.

Thanks!