Regulatory Open Forum

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

Submission of the "documentable" changes is required by section 43(1)(b) of the Canadian Medical Devices Regulations (SOR/98-282, as last amended July 17, 2016).

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

According to page 7 of the attached guidance on Significant Change, "

All changes must be documented in the Quality Management System by the manufacturer. If changes have been found not to be significant by applying the principles of this guidance document and these changes are related to the information and/or documents originally submitted by the manufacturer with respect to the device license application, then the changes must be reported to Health Canada at the time of annual license renewal. These changes should be briefly itemized, in a tabular form with appropriate dates and with any necessary attachments."

I hope this is useful.

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

Thank you all for your feedback. It was very informative and answered all my questions. I had misinterpreted the "may" as the reporting of changes was not a requirement, but I see now that it is. I also learned that this forum is a great place to get answers to questions I may have in the future. Thanks again for all your assistance!

Thank you all for your feedback. It was very informative and answered all my questions. I had misinterpreted the "may" as the reporting of changes was not a requirement, but I see now that it is. I also learned that this forum is a great place to get answers to questions I may have in the future. Thanks again for all your assistance!

According to page 7 of the attached guidance on Significant Change, "

All changes must be documented in the Quality Management System by the manufacturer. If changes have been found not to be significant by applying the principles of this guidance document and these changes are related to the information and/or documents originally submitted by the manufacturer with respect to the device license application, then the changes must be reported to Health Canada at the time of annual license renewal. These changes should be briefly itemized, in a tabular form with appropriate dates and with any necessary attachments."

I hope this is useful.

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

"May," "as applicable," etc, usually means it is required whenever it applies, and you have to figure out if it applies.  Examples are given in an effort to help you figure it out, but they are not intended to be exhaustive, because the regulator is a regulator, not a pharma or device company, so it's not in a position to know all the various scenarios to which the requirement might apply.

It's always useful to keep in mind that, when legislatures pass laws and agencies then promulgate regulations and issue guidances, they are often addressing things they haven't ever dealt with before, either.  It's a little like writing a manual on how to build a Frikadoofus machine, when no one has ever seen one before, much less built one.

Thank you all for your feedback. It was very informative and answered all my questions. I had misinterpreted the "may" as the reporting of changes was not a requirement, but I see now that it is. I also learned that this forum is a great place to get answers to questions I may have in the future. Thanks again for all your assistance!

According to page 7 of the attached guidance on Significant Change, "

All changes must be documented in the Quality Management System by the manufacturer. If changes have been found not to be significant by applying the principles of this guidance document and these changes are related to the information and/or documents originally submitted by the manufacturer with respect to the device license application, then the changes must be reported to Health Canada at the time of annual license renewal. These changes should be briefly itemized, in a tabular form with appropriate dates and with any necessary attachments."

I hope this is useful.

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!

Hi Everyone,

Many thanks for the discussion thread. I found it very useful and always good to have a clearer understanding of the renewal requirements.

From the thread it is clear that we are obliged to provide any non-significant changes progressed under a company’s QMS that are “related to the information and/or documents originally submitted by the manufacturer with respect to the device license application then the changes must be reported to Health Canada at the time of annual license renewal”.

I have an additional question on the same conversation that I hope someone can clarify for me.

According to HC’s license renewal guidance the renewal period covers the previous calendar year e.g. for 2016 this will cover sales from Jan-Dec 2015.

Where non-significant changes have been documented with the QMS but are related to the information held on file by HC should these changes also cover the same period e.g. Jan-Dec2015?

My understanding is that it should since the renewal period is defined as the previous calendar month. Work colleagues think otherwise and that it should include changes up the renewal submission. What are others thoughts on this?

Thanks,

"May," "as applicable," etc, usually means it is required whenever it applies, and you have to figure out if it applies.  Examples are given in an effort to help you figure it out, but they are not intended to be exhaustive, because the regulator is a regulator, not a pharma or device company, so it's not in a position to know all the various scenarios to which the requirement might apply.

It's always useful to keep in mind that, when legislatures pass laws and agencies then promulgate regulations and issue guidances, they are often addressing things they haven't ever dealt with before, either.  It's a little like writing a manual on how to build a Frikadoofus machine, when no one has ever seen one before, much less built one.

Thank you all for your feedback. It was very informative and answered all my questions. I had misinterpreted the "may" as the reporting of changes was not a requirement, but I see now that it is. I also learned that this forum is a great place to get answers to questions I may have in the future. Thanks again for all your assistance!

According to page 7 of the attached guidance on Significant Change, "

All changes must be documented in the Quality Management System by the manufacturer. If changes have been found not to be significant by applying the principles of this guidance document and these changes are related to the information and/or documents originally submitted by the manufacturer with respect to the device license application, then the changes must be reported to Health Canada at the time of annual license renewal. These changes should be briefly itemized, in a tabular form with appropriate dates and with any necessary attachments."

I hope this is useful.

My company is in the process of renewing the annual medical device license for a Class III medical device in Canada. Per the license renewal guidance document "You may also include a table of any documentable changes (changes that do not require an amendment under Section 34) that have been made to your devices in the email with your renewal forms." It seems that submitting a table of documentable changes is not a requirement, can anyone confirm my understanding of this? Also, has anyone experienced any audit findings or observations when they did not submit the table of changes with the license renewal forms for non substantial labeling changes? Thanks in advance!