MDSAP Withdrawal?

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#1
#1
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!
 
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#2
#2
I don't think you need to withdraw from MDSAP per se, but you do need to notify Health Canada about delisting the products and removing the MDL (Medical Device Licences). I would also notify the company that certified the MDSAP and let them know that you have no plans to continue with the program. That way, they won't plan for another audit in the future.

Regarding selling in Canada, I have heard of companies in similar situations who found distributors in Canada and have the products fall under their MDSAP program (not sure how that works, however). We also withdrew from Europe when the new reg's came out. The cost of the program was greater than the profit we were generating. I have also spoken with the head of medical device licensing at Health Canada and warned them about companies withdrawing for the Canadian market.
 
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