Regulatory Open Forum

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Hi Kevin,

Thanks for this summary, saw this was coming and like you said seems to align a bit with EU MDR but still has some additional items to be aware.

I like how they have been pragmatic to include the Foreign Risk Notification - this is so much better than just submitting any and all incident reports from foreign instances.  Other regulatory groups get inundated with incident reports which I guess is important to them, but I think creates a lot more noise than really see significant issues in the field.  Always liked Health Canada as they take good items from other industry processes and implement.

Although as you said it should not impact QMS processes that much, this is one of those 'changes to regulatory requirements' which needs to be included in the process and management review.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Jun-2021 13:35
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won't require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

2. Effective 23 June 2021, Canada's Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a "Summary Report" which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada's new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated "Summary Report" template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR's PMSR and PSUR.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Hi Kevin,

Thank you, I have been working on incorporating this into our QMS. I note that although the new guidance(s) talk about incident reporting, the cMDR still talks about mandatory problem reporting. Anyone know if this will be updated? I believe I'm looking at the current cMDR: SOR/98-282, last amended March 31, 2021; current to June 3, 2021.

Thank you,

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
------------------------------

Original Message:
Sent: 18-Jun-2021 13:35
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won't require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

2. Effective 23 June 2021, Canada's Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a "Summary Report" which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada's new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated "Summary Report" template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR's PMSR and PSUR.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Hi Corey,

Yep, an official version of SOR/98-282 will be updated in due course after the changes are in force (remember that these amendments aren't yet in force until 6/23/2021 and 12/23/2021).  You can see what the exact new text of SOR/98-282 will be in the amending regulation SOR/2020-262 at here.  For example, therein you'll see in section 13 that the heading ("Mandatory Problem Reporting") before section 59 of the CMDR is replaced by "Incident Reporting".

Expect a new consolidated version at Canada's Justice Laws website after the amendments go into effect.  Accordingly, I wouldn't expect to see the changes effective 12/23/2021 to be added to the consolidated version at Justice Laws until after 12/23/2021.  But the amendments effective this week (6/23/2021) should appear in the consolidated version in a few weeks time or sooner.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 21-Jun-2021 10:41
From: Corey Jaseph
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Hi Kevin,

Thank you, I have been working on incorporating this into our QMS. I note that although the new guidance(s) talk about incident reporting, the cMDR still talks about mandatory problem reporting. Anyone know if this will be updated? I believe I'm looking at the current cMDR: SOR/98-282, last amended March 31, 2021; current to June 3, 2021.

Thank you,

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 18-Jun-2021 13:35
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won't require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

2. Effective 23 June 2021, Canada's Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a "Summary Report" which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada's new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated "Summary Report" template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR's PMSR and PSUR.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Broken link has been fixed.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 21-Jun-2021 14:53
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Hi Corey,

Yep, an official version of SOR/98-282 will be updated in due course after the changes are in force (remember that these amendments aren't yet in force until 6/23/2021 and 12/23/2021).  You can see what the exact new text of SOR/98-282 will be in the amending regulation SOR/2020-262 at here.  For example, therein you'll see in section 13 that the heading ("Mandatory Problem Reporting") before section 59 of the CMDR is replaced by "Incident Reporting".

Expect a new consolidated version at Canada's Justice Laws website after the amendments go into effect.  Accordingly, I wouldn't expect to see the changes effective 12/23/2021 to be added to the consolidated version at Justice Laws until after 12/23/2021.  But the amendments effective this week (6/23/2021) should appear in the consolidated version in a few weeks time or sooner.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 21-Jun-2021 10:41
From: Corey Jaseph
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Hi Kevin,

Thank you, I have been working on incorporating this into our QMS. I note that although the new guidance(s) talk about incident reporting, the cMDR still talks about mandatory problem reporting. Anyone know if this will be updated? I believe I'm looking at the current cMDR: SOR/98-282, last amended March 31, 2021; current to June 3, 2021.

Thank you,

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 18-Jun-2021 13:35
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won't require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

2. Effective 23 June 2021, Canada's Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a "Summary Report" which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada's new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated "Summary Report" template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR's PMSR and PSUR.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Thanks, Kevin!

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States
------------------------------

Original Message:
Sent: 21-Jun-2021 14:53
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Hi Corey,

Yep, an official version of SOR/98-282 will be updated in due course after the changes are in force (remember that these amendments aren't yet in force until 6/23/2021 and 12/23/2021).  You can see what the exact new text of SOR/98-282 will be in the amending regulation SOR/2020-262 at here.  For example, therein you'll see in section 13 that the heading ("Mandatory Problem Reporting") before section 59 of the CMDR is replaced by "Incident Reporting".

Expect a new consolidated version at Canada's Justice Laws website after the amendments go into effect.  Accordingly, I wouldn't expect to see the changes effective 12/23/2021 to be added to the consolidated version at Justice Laws until after 12/23/2021.  But the amendments effective this week (6/23/2021) should appear in the consolidated version in a few weeks time or sooner.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 21-Jun-2021 10:41
From: Corey Jaseph
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Hi Kevin,

Thank you, I have been working on incorporating this into our QMS. I note that although the new guidance(s) talk about incident reporting, the cMDR still talks about mandatory problem reporting. Anyone know if this will be updated? I believe I'm looking at the current cMDR: SOR/98-282, last amended March 31, 2021; current to June 3, 2021.

Thank you,

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
Wheatland CA
United States

Original Message:
Sent: 18-Jun-2021 13:35
From: Kevin Randall
Subject: Health Canada Revised CMDR Starts Coming Into Force in a Few Days

Here's a quick recap of Health Canada's changes to the Medical Devices Regulations (SOR/98-282) that start coming into force in a few days on 23 June:

1. Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc.  Generally, this won't require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.

2. Effective 23 June 2021, Canada's Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:

1. 1. Canadian "Mandatory Problem" reporting is now Canadian "Incident" reporting.
   2. Foreign incident reporting is now limited to Class I devices; yet
   3. Class II, III, and IV foreign incident reporting has been replaced with a new process called "Foreign Risk Notification".

3. Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a "Summary Report" which may in certain circumstances require submission to Health Canada within 72 hours.  An associated seven-year record keeping requirement is included.  Corresponding procedures should be integrated into our QMS procedures for PMS.  I found that Canada's new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks.  I also recommend a designated "Summary Report" template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR's PMSR and PSUR.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada. Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------