Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

This guidance was published in January and becomes effective on June 23rd. We are having trouble understanding whether it applies only to approved devices, or also to devices under clinical investigation.

Evidence for it applying to post-market only:

• Guidance was released as part of an initiative to strengthen post-market surveillance and risk management of medical devices. 
• The background of the guidance mentions GHTF "Medical Devices Post Market Surveillance" (N54) and seems to align this document with the GHTF one. 
• The language in section 2.2 indicates it applies to devices "authorized for sale". 

On the other hand:

• Both pre- and post-market reporting are governed by the same sections of the Canadian Medical Devices Regulations (Parts 59 to 61). 
• The definition of "sell" in the Canada Food and Drug Act is "offer for sale, expose for sale or have in possession to sale - or distribute to one or more persons, whether or not the distribution is made for consideration", so this does not preclude selling for the purpose of investigational testing. In fact the ITA guidance refers to selling throughout, including that the ITA letter is "the manufacturer's legal authorization to import and sell the requisite number of devices to the investigators or institutions listed under the Authorization for use in the referenced study protocol".

Does anyone have a definitive answer as to the intended scope of this new guidance?

Thanks,
Anon.

The new Health Canada guidance "Incident reporting for medical devices" effective June 23, 2021, as well as the corresponding regulatory changes (see SOR/2020-262) that come into force on the same day, apply both to devices for which a market authorization exists and also to devices under clinical investigation.  This is based on Section 88(c) of the CMDR as clerically amended by SOR/2020-262.

------------------------------
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: 15-Jun-2021 19:09
From: Anonymous Member
Subject: Health Canada "Incident reporting for medical devices" guidance

This message was posted by a user wishing to remain anonymous

This guidance was published in January and becomes effective on June 23rd. We are having trouble understanding whether it applies only to approved devices, or also to devices under clinical investigation.

Evidence for it applying to post-market only:

• Guidance was released as part of an initiative to strengthen post-market surveillance and risk management of medical devices. 
• The background of the guidance mentions GHTF "Medical Devices Post Market Surveillance" (N54) and seems to align this document with the GHTF one. 
• The language in section 2.2 indicates it applies to devices "authorized for sale". 

On the other hand:

• Both pre- and post-market reporting are governed by the same sections of the Canadian Medical Devices Regulations (Parts 59 to 61). 
• The definition of "sell" in the Canada Food and Drug Act is "offer for sale, expose for sale or have in possession to sale - or distribute to one or more persons, whether or not the distribution is made for consideration", so this does not preclude selling for the purpose of investigational testing. In fact the ITA guidance refers to selling throughout, including that the ITA letter is "the manufacturer's legal authorization to import and sell the requisite number of devices to the investigators or institutions listed under the Authorization for use in the referenced study protocol".

Does anyone have a definitive answer as to the intended scope of this new guidance?

Thanks,
Anon.

This message was posted by a user wishing to remain anonymous

Thank you Kevin, this is very clear! I had read SOR/2020-262 but somehow missed the connection. 
 
Health Canada certainly doesn't make it easy to interpret these changes! I appreciate your help. 

Anon.
Original Message:
Sent: 16-Jun-2021 12:14
From: Kevin Randall
Subject: Health Canada "Incident reporting for medical devices" guidance

The new Health Canada guidance "Incident reporting for medical devices" effective June 23, 2021, as well as the corresponding regulatory changes (see SOR/2020-262) that come into force on the same day, apply both to devices for which a market authorization exists and also to devices under clinical investigation.  This is based on Section 88(c) of the CMDR as clerically amended by SOR/2020-262.

------------------------------
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: 15-Jun-2021 19:09
From: Anonymous Member
Subject: Health Canada "Incident reporting for medical devices" guidance

This message was posted by a user wishing to remain anonymous

This guidance was published in January and becomes effective on June 23rd. We are having trouble understanding whether it applies only to approved devices, or also to devices under clinical investigation.

Evidence for it applying to post-market only:

• Guidance was released as part of an initiative to strengthen post-market surveillance and risk management of medical devices. 
• The background of the guidance mentions GHTF "Medical Devices Post Market Surveillance" (N54) and seems to align this document with the GHTF one. 
• The language in section 2.2 indicates it applies to devices "authorized for sale". 

On the other hand:

• Both pre- and post-market reporting are governed by the same sections of the Canadian Medical Devices Regulations (Parts 59 to 61). 
• The definition of "sell" in the Canada Food and Drug Act is "offer for sale, expose for sale or have in possession to sale - or distribute to one or more persons, whether or not the distribution is made for consideration", so this does not preclude selling for the purpose of investigational testing. In fact the ITA guidance refers to selling throughout, including that the ITA letter is "the manufacturer's legal authorization to import and sell the requisite number of devices to the investigators or institutions listed under the Authorization for use in the referenced study protocol".

Does anyone have a definitive answer as to the intended scope of this new guidance?

Thanks,
Anon.

Glad to help.  Having tackled Health Canada's CMDR requirements for over 10,000 devices, I've definitely had a unique opportunity to log a lot of miles working through Health Canada's device regulations.

All the best!

------------------------------
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: 16-Jun-2021 15:11
From: Anonymous Member
Subject: Health Canada "Incident reporting for medical devices" guidance

This message was posted by a user wishing to remain anonymous

Thank you Kevin, this is very clear! I had read SOR/2020-262 but somehow missed the connection.

Health Canada certainly doesn't make it easy to interpret these changes! I appreciate your help.

Anon.
Original Message:
Sent: 16-Jun-2021 12:14
From: Kevin Randall
Subject: Health Canada "Incident reporting for medical devices" guidance

The new Health Canada guidance "Incident reporting for medical devices" effective June 23, 2021, as well as the corresponding regulatory changes (see SOR/2020-262) that come into force on the same day, apply both to devices for which a market authorization exists and also to devices under clinical investigation.  This is based on Section 88(c) of the CMDR as clerically amended by SOR/2020-262.

------------------------------
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: 15-Jun-2021 19:09
From: Anonymous Member
Subject: Health Canada "Incident reporting for medical devices" guidance

This message was posted by a user wishing to remain anonymous

This guidance was published in January and becomes effective on June 23rd. We are having trouble understanding whether it applies only to approved devices, or also to devices under clinical investigation.

Evidence for it applying to post-market only:

• Guidance was released as part of an initiative to strengthen post-market surveillance and risk management of medical devices. 
• The background of the guidance mentions GHTF "Medical Devices Post Market Surveillance" (N54) and seems to align this document with the GHTF one. 
• The language in section 2.2 indicates it applies to devices "authorized for sale". 

On the other hand:

• Both pre- and post-market reporting are governed by the same sections of the Canadian Medical Devices Regulations (Parts 59 to 61). 
• The definition of "sell" in the Canada Food and Drug Act is "offer for sale, expose for sale or have in possession to sale - or distribute to one or more persons, whether or not the distribution is made for consideration", so this does not preclude selling for the purpose of investigational testing. In fact the ITA guidance refers to selling throughout, including that the ITA letter is "the manufacturer's legal authorization to import and sell the requisite number of devices to the investigators or institutions listed under the Authorization for use in the referenced study protocol".

Does anyone have a definitive answer as to the intended scope of this new guidance?

Thanks,
Anon.