Has anyone gone through the withdrawal process for the MDSAP program?
I am working with a small US-based company that previously distributed in the US, Europe, Canada and Brazil. There have been some large shifts in strategy though, and distribution for all products has been limited to US only. They canceled their EC Certificate last year, but still have an active Canadian medical license. The last MDSAP audit was performed last year against just US/Canada requirements.
The next audit is scheduled for October, but we are currently planning a significant QMS overhaul and migration to a cloud-based system. Current systems are very Europe/EUMDR-centric, and there are no plans to return to that market. This would allow us some time to focus on the transfer and build up history in the new system before eventually reapplying to the program if and when there was a need.
I know that this would restrict the ability to distribute in Canada and put the facility back on the routine inspection list for the FDA. Are there any additional risks with this course of action, and/or does anyone have any experience with the withdrawal process?
Any input greatly appreciated!
I am working with a small US-based company that previously distributed in the US, Europe, Canada and Brazil. There have been some large shifts in strategy though, and distribution for all products has been limited to US only. They canceled their EC Certificate last year, but still have an active Canadian medical license. The last MDSAP audit was performed last year against just US/Canada requirements.
The next audit is scheduled for October, but we are currently planning a significant QMS overhaul and migration to a cloud-based system. Current systems are very Europe/EUMDR-centric, and there are no plans to return to that market. This would allow us some time to focus on the transfer and build up history in the new system before eventually reapplying to the program if and when there was a need.
I know that this would restrict the ability to distribute in Canada and put the facility back on the routine inspection list for the FDA. Are there any additional risks with this course of action, and/or does anyone have any experience with the withdrawal process?
Any input greatly appreciated!