MDSAP Participants 2019 - How many companies are participating YTD?

QMS for Life Sciences
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Edward Reesor

Edward Reesor

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#2
#2
I know of many companies that chose not to remain in the Canadian market after MDSAP became mandatory. Several of our distributors are in similar circumstances where they lost significant product lines and access to innovative technology. One way is to contact Health Canada and/or your MP for information. I have messaged my contact in Health Canada with this very question and am waiting for a response. I will keep you posted.
 
Salisburysteve

Salisburysteve

Starting to get Involved
#3
#3
We have been unable to justify the cost of MDSAP against our Canadian sales. Health Canada have reached out to involve BSI (AO) in trying to ensure our quotation had been prepared correctly. I am in the process of following this up. Apparently 2% of license holders have withdrawn - which doesn't sound a lot but if you are an affected patient then it is still denial of technology that much of the rest of the world has access to.
Regards,
Steve
 
Watchcat

Watchcat

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#5
#5
If they aren't posting these data transparently, I would take that as evidence that the program is not going nearly as well as various players would like everyone to think it is. And/or perhaps that it is not providing the benefits that were promised to various parties.
 
Watchcat

Watchcat

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#6
#6
pkost, my first guess is that any impact analysis was limited to the impact on Health Canada's budget and staffing. My second guess is that Health Canada did not come up with this bright idea all on its own, and therefore may have been relying on impact assessments done by others.
 
Last edited:
Salisburysteve

Salisburysteve

Starting to get Involved
#8
#8
This information was derived from a conversation I had with an HC official. "98% of (licence holders)/(licenses) have renewed with MDSAP"
Brackets because I can't remember the exact phrase and it could make a difference.
I don't know if it is published. BSI Americas have emailed me but I haven't had time to respond.
 
D

DannyK

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#10
#10
It does not help that some auditing organizations have doubled their fees for MDSAP knowing that there are not many alternatives. Health Canada is not sharing because the truth is that many more companies have decided to abandon Canada. Some Canadian distributors have contacted me to set-up MDSAP for them so that they could continue distributing their devices.
 
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