Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Summary reports to Health Canada are required to be submitted when there has been a change in the benefits and risks of your medical device. I am wondering if someone on the forum can provide a little more clarity as after reading the guidance I am still unsure of Canada's intent. Is the intent to submit the summary report with any negative change to the probability of occurrence and/or severity of harm? Or is Canada's intent that the summary report will only be submitted when there is an overall change in the benefit-risk assessment?

In this case, I think it's best to use the Regulation itself to understand Health Canada's trigger criteria for Summary Reports.  That Regulation is SOR/2020-262.  It requires a Summary Report of the information that pertains to:

1. adverse effects;
2. reported problems (via complaints) relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada;
3. reportable incidents; and
4. serious risks of injury to human health that are relevant to the safety of the medical device and referred to in subsection 61.2(2) of the CMDR.

The Summary Report must contain a concise critical analysis of the aforementioned information.

Based on this analysis, you need to decide whether what is known about the benefits and risks associated with the subject device has changed with respect to any of the following parameters:

• any of the benefits that may be obtained by patients through the use of the medical device could be less;
• in respect of any of the risks,

1. 1. the risk is more likely to occur, or
   2. if the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and

• a new risk has been identified.

Also, be sure to remember that Health Canada Summary Reports only apply to Canadian Class II, III, and IV devices.

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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Nov-2022 17:01
From: Anonymous Member
Subject: Health Canada Summary Report- When to Submit?

This message was posted by a user wishing to remain anonymous

Summary reports to Health Canada are required to be submitted when there has been a change in the benefits and risks of your medical device. I am wondering if someone on the forum can provide a little more clarity as after reading the guidance I am still unsure of Canada's intent. Is the intent to submit the summary report with any negative change to the probability of occurrence and/or severity of harm? Or is Canada's intent that the summary report will only be submitted when there is an overall change in the benefit-risk assessment?

Hi,

I have a question related to what OP has asked above. If a manufacturer's device has not undergone any change in risks/benefits in several years, but that manufacturer has not yet prepared a summary report...would the first such summary report for the device need to be submitted to Health Canada, despite there being no changes to risks/benefits for the device?

In other words - I understand that subsequent reports would only need to be submitted if there is a change to risks/benefits of the device, but would the initial summary report need to be submitted regardless of whether there are any such changes? Or would it only need to be filed?

Thanks!

------------------------------
Thomas Saladin
Regulatory Affairs Specialist
Laborie Medical Technologies Canada ULC
Minnetonka MN
United States
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Original Message:
Sent: 12-Nov-2022 17:45
From: Kevin Randall
Subject: Health Canada Summary Report- When to Submit?

In this case, I think it's best to use the Regulation itself to understand Health Canada's trigger criteria for Summary Reports.  That Regulation is SOR/2020-262.  It requires a Summary Report of the information that pertains to:

1. adverse effects;
2. reported problems (via complaints) relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada;
3. reportable incidents; and
4. serious risks of injury to human health that are relevant to the safety of the medical device and referred to in subsection 61.2(2) of the CMDR.

The Summary Report must contain a concise critical analysis of the aforementioned information.

Based on this analysis, you need to decide whether what is known about the benefits and risks associated with the subject device has changed with respect to any of the following parameters:

• any of the benefits that may be obtained by patients through the use of the medical device could be less;
• in respect of any of the risks,

1. 1. the risk is more likely to occur, or
   2. if the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and

• a new risk has been identified.

Also, be sure to remember that Health Canada Summary Reports only apply to Canadian Class II, III, and IV devices.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 11-Nov-2022 17:01
From: Anonymous Member
Subject: Health Canada Summary Report- When to Submit?

This message was posted by a user wishing to remain anonymous

Summary reports to Health Canada are required to be submitted when there has been a change in the benefits and risks of your medical device. I am wondering if someone on the forum can provide a little more clarity as after reading the guidance I am still unsure of Canada's intent. Is the intent to submit the summary report with any negative change to the probability of occurrence and/or severity of harm? Or is Canada's intent that the summary report will only be submitted when there is an overall change in the benefit-risk assessment?

Hi there - You would not need to report individual changes to probabilities and severities, but rather, if there any resulting changes to the risk-benefit profile of the device.
The conclusion section of the guidance states "For the purposes of this guidance document, a "change" has occurred when it's believed the device may no longer meet the applicable requirements (sections 10 to 20 of the Regulations). This belief should be based on the critical analysis that was completed as part of the summary report (section 61.4(3) of the Regulations)."
Good luck!

------------------------------
Nomi Steen
Regulatory Affairs Associate
Edmonton AB
Canada
------------------------------

Original Message:
Sent: 11-Nov-2022 17:01
From: Anonymous Member
Subject: Health Canada Summary Report- When to Submit?

This message was posted by a user wishing to remain anonymous

Summary reports to Health Canada are required to be submitted when there has been a change in the benefits and risks of your medical device. I am wondering if someone on the forum can provide a little more clarity as after reading the guidance I am still unsure of Canada's intent. Is the intent to submit the summary report with any negative change to the probability of occurrence and/or severity of harm? Or is Canada's intent that the summary report will only be submitted when there is an overall change in the benefit-risk assessment?

Hi Thomas

If the first annual/biannual report shows a "change" to the benefits and risks of your medical device since the information that was provided in the MDL application, Health Canada wants to know about it. If not, it just gets filed.

https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/medical-device-reports-analyses-guidance-en.pdf

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Anne LeBlanc
United States
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Original Message:
Sent: 14-Nov-2022 12:22
From: Nomi Steen
Subject: Health Canada Summary Report- When to Submit?

Hi there - You would not need to report individual changes to probabilities and severities, but rather, if there any resulting changes to the risk-benefit profile of the device.
The conclusion section of the guidance states "For the purposes of this guidance document, a "change" has occurred when it's believed the device may no longer meet the applicable requirements (sections 10 to 20 of the Regulations). This belief should be based on the critical analysis that was completed as part of the summary report (section 61.4(3) of the Regulations)."
Good luck!

------------------------------
Nomi Steen
Regulatory Affairs Associate
Edmonton AB
Canada

Original Message:
Sent: 11-Nov-2022 17:01
From: Anonymous Member
Subject: Health Canada Summary Report- When to Submit?

This message was posted by a user wishing to remain anonymous

Summary reports to Health Canada are required to be submitted when there has been a change in the benefits and risks of your medical device. I am wondering if someone on the forum can provide a little more clarity as after reading the guidance I am still unsure of Canada's intent. Is the intent to submit the summary report with any negative change to the probability of occurrence and/or severity of harm? Or is Canada's intent that the summary report will only be submitted when there is an overall change in the benefit-risk assessment?