Performance standards for all types of applications (both drug and device) can be found here:
Performance standards for the fees in respect of drugs and medical devices order - Canada.caFor a Class 2 MDL, you are looking at 15 days.
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Joseph De Croos PhD
Director, Quality Assurance & Regulatory Affairs
Kitchener ON
Canada
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Original Message:
Sent: 05-Dec-2022 19:23
From: Anonymous Member
Subject: Health Canada Screening and Review Timelines
This message was posted by a user wishing to remain anonymous
Hi,
What is the timeline for a new HC Class 2 MDL application approval time?
Where can i find the timelines published just like MDUFA goals?
Thanks!
Original Message:
Sent: 09-Jul-2021 11:29
From: Shirley Furesz
Subject: Health Canada Screening and Review Timelines
Hi,
Health Canada's target of 15 days to screen a Class III licence application (non-COVID-19 related) is definitively taking longer. I has submitted a Class III licence application back last fall and it took 12 weeks to screen!! I also submitted one more recently in the middle of June and received screening acceptance 5 weeks later...so definitely better than last fall. Once you pass screening, the targets for review (i.e. 60 calendar days for a Class III) are being met about 90% of the time as these timelines are under the cost-recovery requirement and if they don't meet the timeline, then they have to pay the applicant! So, I'd expect either an Additional information request or if you are lucky, the issued licence very close to the 60 days following screening acceptance.
Hope this helps!
Shirley
Shirley Furesz, Ph.D., RAC
Amerisource Bergen
TPIreg, Innomar Strategies
Director Regulatory Affairs, Medical Devices
Cell phone: 519-242-6476
Fax: 888-887-8686
3470 Superior Court
Oakville ON L6L0C4
Canada
www.innomar-strategies.com
United in our responsibility
to create healthier futures
Original Message:
Sent: 7/7/2021 7:18:00 PM
From: Anonymous Member
Subject: RE: Health Canada Screening and Review Timelines
This message was posted by a user wishing to remain anonymous
Based on my experience it does take time (longer than committed by Health Canada)
Even when we used the interim order their response time took longer than committed.
I still believe they have a huge backlog and prioritizing COVID-related devices.
Original Message:
Sent: 06-Jul-2021 08:56
From: Anonymous Member
Subject: Health Canada Screening and Review Timelines
This message was posted by a user wishing to remain anonymous
If anyone has experience with Health Canada device submissions, what is the timeline for screening of a Class III submission? According to their guidance, it's about 15 days. But it looks like it's taking much longer than that. It's been more than 1 month. The last Class IV submission during the pandemic took 1 month to screen.
I presume the pandemic affects their target screening timeline? Thanks very much.