Regulatory Open Forum

Hi everyone, 

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Karen,
I’ve submitted amendments for Class II devices for the types of changes you are describing - addition/deletion of model numbers. The amendment application is simple, and you need to attach very few documents (I think it was just revised labeling and the current QMS cert). They amendment can be sent as a zipped folder by email and turnaround time is very quick - 2-3 weeks in my experience.

---------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
---------------------------------



Original Message:
Sent: 24-Aug-2020
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone, 

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Hiral, Did you follow the IMDRF TOC when you submitted the amendments for Class2 ?

Thanks,​

------------------------------
Shilpa Pillai
Naperville IL
United States
------------------------------

Original Message:
Sent: 24-Aug-2020 09:57
From: Hiral Dutia
Subject: Administrative Amendment - Health Canada

Hi Karen,
I've submitted amendments for Class II devices for the types of changes you are describing - addition/deletion of model numbers. The amendment application is simple, and you need to attach very few documents (I think it was just revised labeling and the current QMS cert). They amendment can be sent as a zipped folder by email and turnaround time is very quick - 2-3 weeks in my experience.

---------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 24-Aug-2020
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Shilpa, I did not and followed the Health Canada guidance instead. Note that it's been 1-2 years since the last amendment, and at the time, Health Canada was not pushing to follow the IMDRF TOC. I've seen recent threads that suggest that has changed.

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 25-Aug-2020 09:22
From: Shilpa Pillai
Subject: Administrative Amendment - Health Canada

Hi Hiral, Did you follow the IMDRF TOC when you submitted the amendments for Class2 ?

Thanks,​

------------------------------
Shilpa Pillai
Naperville IL
United States

Original Message:
Sent: 24-Aug-2020 09:57
From: Hiral Dutia
Subject: Administrative Amendment - Health Canada

Hi Karen,
I've submitted amendments for Class II devices for the types of changes you are describing - addition/deletion of model numbers. The amendment application is simple, and you need to attach very few documents (I think it was just revised labeling and the current QMS cert). They amendment can be sent as a zipped folder by email and turnaround time is very quick - 2-3 weeks in my experience.

---------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 24-Aug-2020
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Karen,


It may depend on what type of change it is and how much information Health Canada would need to review.  For example, I've submitted Class III amendments for various non-significant changes that needed to made all at once (e.g. licence name, device name, change in model numbers etc.).  These applications didn't require review of additional technical/scientific information. 

There are other changes (e.g. addition of Class II device to a Class III or IV system licence) which may not be completely administrative, though the information required may be limited compared to the information required for a significant change submission.

Regards,

Camille

------------------------------
Camille Thorpe, RAC
Toronto, ON
Canada
------------------------------

Original Message:
Sent: 24-Aug-2020 09:44
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Karen,
To clarify, the addition/deletion of model numbers and changes in the manufacturing address are both non-significant changes that can be addressed via different fax back forms. I'm not familiar with "administrative" medical device license amendments (other than the non-significant changes that are addressed via fax back forms), but aware this exists for pharma.
Can you share what the scope of changes are? If not, I would recommend submitting a license amendment using the Health Canada folder structure, clearly outlining the administrative changes within the cover letter, executive summary, and license amendment sections (to cover all bases) and deleting all folders not impacted by the administrative changes (and addressing this within the aforementioned sections). 
Good luck!

------------------------------
Nomi Steen
Regulatory Affairs Associate
Elkton MD
United States
------------------------------

Original Message:
Sent: 24-Aug-2020 09:44
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

FYI - Per a recent (May) communication from Medtech Canada regarding the fee form not allowing a $0 entry for administrative changes, Health Canada's response is as follows: "For the time being, if you wish to make an administrative amendment you can omit submitting a fee form with your application and in its place include a rationale in your cover letter justifying an administrative amendment that is not subject to any fees. In addition to the cover letter you can also leave a note in the fee form section of the folder structure, reiterating your rationale, to minimize any further complications".

*Also, wanted to correct one point in my previous statement. While changes to the manufacturing address can be addressed via a fax back form, it's not considered a non-significant change.

------------------------------
Nomi Steen
Regulatory Affairs Associate
Elkton MD
United States
------------------------------

Original Message:
Sent: 24-Aug-2020 09:44
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Nomi,

Do you have a link to this communication? 

Thanks.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 03-Sep-2020 14:40
From: Nomi Steen
Subject: Administrative Amendment - Health Canada

FYI - Per a recent (May) communication from Medtech Canada regarding the fee form not allowing a $0 entry for administrative changes, Health Canada's response is as follows: "For the time being, if you wish to make an administrative amendment you can omit submitting a fee form with your application and in its place include a rationale in your cover letter justifying an administrative amendment that is not subject to any fees. In addition to the cover letter you can also leave a note in the fee form section of the folder structure, reiterating your rationale, to minimize any further complications".

*Also, wanted to correct one point in my previous statement. While changes to the manufacturing address can be addressed via a fax back form, it's not considered a non-significant change.

------------------------------
Nomi Steen
Regulatory Affairs Associate
Elkton MD
United States

Original Message:
Sent: 24-Aug-2020 09:44
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.

Hi Karen -
See attached for e-mail communication.
Best regards,

------------------------------
Nomi Steen
Regulatory Affairs Associate
Elkton MD
United States
------------------------------

Original Message:
Sent: 03-Sep-2020 14:45
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi Nomi,

Do you have a link to this communication?

Thanks.

------------------------------
Karen Zhou

Original Message:
Sent: 03-Sep-2020 14:40
From: Nomi Steen
Subject: Administrative Amendment - Health Canada

FYI - Per a recent (May) communication from Medtech Canada regarding the fee form not allowing a $0 entry for administrative changes, Health Canada's response is as follows: "For the time being, if you wish to make an administrative amendment you can omit submitting a fee form with your application and in its place include a rationale in your cover letter justifying an administrative amendment that is not subject to any fees. In addition to the cover letter you can also leave a note in the fee form section of the folder structure, reiterating your rationale, to minimize any further complications".

*Also, wanted to correct one point in my previous statement. While changes to the manufacturing address can be addressed via a fax back form, it's not considered a non-significant change.

------------------------------
Nomi Steen
Regulatory Affairs Associate
Elkton MD
United States

Original Message:
Sent: 24-Aug-2020 09:44
From: Karen Zhou
Subject: Administrative Amendment - Health Canada

Hi everyone,

Has anyone had much experience with administrative amendments with Health Canada?  These are medical device amendment applications that are not considered significant changes but they are not fax-backs either (simple addition and deletion of model numbers, changes in manufacturing address). What kinds of changes would fall under an admin amendment?

Thanks.