Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
I was wondering if anyone has had any experience within the last few months with Class II application for Health Canada? We've submitted several applications within the last few months (both Class II and Class III), and have received approval all within the timelines expected for all of the applications with the exception of one Class II application.

As of right now the Class II application has been with Health Canada for a total of 58 days.  We received a screening deficiency back in September and responded within 5 days, and have not heard anything since.  The reviewer also reviewed some of the other Class II applications which we had submitted, and have since received approval for.  They were approved anywhere from 15-30 days.  There really isn't a significant difference with these instruments compared to the ones that have received approval, and it is not a complex instrument.

Has anyone been experiencing these kinds of delays recently?  I just find it odd that we've received responses for all of our other application within the expected timelines, and this one seems to be stuck in limbo.

Hello,

I have submitted a number of Class II and III licence applications for clients over the last few months and there has been a wide variation in the processing times, though most of them have been longer than the target timelines.  This is not surprising considering the number of additional submissions Health Canada has received due to COVID-19 compared to their staffing capabilities (even with them hiring/moving staff to help with this huge increase in workload).

Have you tried to reach out to the contact person who sent the screening deficiency request to you to see where in queue the application is.  Some of the staff are more willing to give you updates than others.  That said, MDD's preferred way of asking for an update is to send an email to the general email address (Device Licensing / Homologation Instruments (HC/SC), hc.devicelicensing-homologationinstruments.sc@canada.ca).

I have a Class II application that was submitted the middle of September (along with 2 related applications).  We received a clarification question at the end of Sept, that was responded to the same day.  We then received a second clarification question a couple days later (beginning of October) which we responded to a week later.  It has now been 6 weeks since that response was submitted and we still have not heard anything back.  The other two licence applications that were submitted at the same time have since been issued a while ago.

Similarly, for a Class III licence application that was submitted in September, it has been 2 months now and we have not heard anything regarding whether a screening deficiency letter or a screening acceptance will be issued.  All I know is that on Nov. 10 the application was "picked up for technical screening".  So the target timeline of 15 calendar days for screening is way off.

As you can see, they are way behind... 

Good luck!

Shirley​

------------------------------
Shirley Furesz RAC
Director, Regulatory Affairs Medical Devices
Oakville Canada
5192426476
sfuresz@tpireg.com
------------------------------

Original Message:
Sent: 20-Nov-2020 09:33
From: Anonymous Member
Subject: Health Canada Class II application

This message was posted by a user wishing to remain anonymous

Hello,
I was wondering if anyone has had any experience within the last few months with Class II application for Health Canada? We've submitted several applications within the last few months (both Class II and Class III), and have received approval all within the timelines expected for all of the applications with the exception of one Class II application.

As of right now the Class II application has been with Health Canada for a total of 58 days.  We received a screening deficiency back in September and responded within 5 days, and have not heard anything since.  The reviewer also reviewed some of the other Class II applications which we had submitted, and have since received approval for.  They were approved anywhere from 15-30 days.  There really isn't a significant difference with these instruments compared to the ones that have received approval, and it is not a complex instrument.

Has anyone been experiencing these kinds of delays recently?  I just find it odd that we've received responses for all of our other application within the expected timelines, and this one seems to be stuck in limbo.

This message was posted by a user wishing to remain anonymous

Hi Shirley,
Thanks so much for your response.  It sounds like you are experiencing a similar situation.  I do plan to reach out to person who issued the deficiency request if I don't hear anything within the next two weeks or so.  I have also thought about sending an email to the general email address, but I sent an inquiry to them back in the beginning of the year and have yet to hear anything back so I think that will be my last resort :)

Thanks again, and hope you hear something on your applications soon!

Original Message:
Sent: 21-Nov-2020 12:00
From: Shirley Furesz
Subject: Health Canada Class II application

Hello,

I have submitted a number of Class II and III licence applications for clients over the last few months and there has been a wide variation in the processing times, though most of them have been longer than the target timelines.  This is not surprising considering the number of additional submissions Health Canada has received due to COVID-19 compared to their staffing capabilities (even with them hiring/moving staff to help with this huge increase in workload).

Have you tried to reach out to the contact person who sent the screening deficiency request to you to see where in queue the application is.  Some of the staff are more willing to give you updates than others.  That said, MDD's preferred way of asking for an update is to send an email to the general email address (Device Licensing / Homologation Instruments (HC/SC), hc.devicelicensing-homologationinstruments.sc@canada.ca).

I have a Class II application that was submitted the middle of September (along with 2 related applications).  We received a clarification question at the end of Sept, that was responded to the same day.  We then received a second clarification question a couple days later (beginning of October) which we responded to a week later.  It has now been 6 weeks since that response was submitted and we still have not heard anything back.  The other two licence applications that were submitted at the same time have since been issued a while ago.

Similarly, for a Class III licence application that was submitted in September, it has been 2 months now and we have not heard anything regarding whether a screening deficiency letter or a screening acceptance will be issued.  All I know is that on Nov. 10 the application was "picked up for technical screening".  So the target timeline of 15 calendar days for screening is way off.

As you can see, they are way behind...

Good luck!

Shirley​

------------------------------
Shirley Furesz RAC
Director, Regulatory Affairs Medical Devices
Oakville Canada
5192426476
sfuresz@tpireg.com

Original Message:
Sent: 20-Nov-2020 09:33
From: Anonymous Member
Subject: Health Canada Class II application

This message was posted by a user wishing to remain anonymous

Hello,
I was wondering if anyone has had any experience within the last few months with Class II application for Health Canada? We've submitted several applications within the last few months (both Class II and Class III), and have received approval all within the timelines expected for all of the applications with the exception of one Class II application.

As of right now the Class II application has been with Health Canada for a total of 58 days.  We received a screening deficiency back in September and responded within 5 days, and have not heard anything since.  The reviewer also reviewed some of the other Class II applications which we had submitted, and have since received approval for.  They were approved anywhere from 15-30 days.  There really isn't a significant difference with these instruments compared to the ones that have received approval, and it is not a complex instrument.

Has anyone been experiencing these kinds of delays recently?  I just find it odd that we've received responses for all of our other application within the expected timelines, and this one seems to be stuck in limbo.