MDSAP (Medical Device Single Audit Program) Costs

[Edward Reesor]

Health Canada recently announced a decrease in MDSAP fees (up to 20% lower for companies with less that 15 employees). I have been told that the MDSAP audit process will be 2 auditors for 5 days, meaning that a small company would have that reduced to 4 days each.

This is still a significant increase in fees and I have been told by three distributors that their product lines may be cut off by foreign manufacturers who are considering leaving the Canadian market.

Can anyone else shed light on their experience regarding net cost increase for the MDSAP program and decisions to leave/stay in the Canadian marketplace?

 

[mihzago]

From what I've heard, the largest increase seems to be for small companies.
For mine, it nearly tripled the cost and duration. I've heard about similar increase from a few other people.

 

[Mark Meer]

Health Canada recently announced a decrease in MDSAP fees (up to 20% lower for companies with less that 15 employees). I have been told that the MDSAP audit process will be 2 auditors for 5 days, meaning that a small company would have that reduced to 4 days each.

Can Health Canada do this? It was my understanding that the time calculation was baked into the MDSAP program specifications, agreed on by all 5 regulatory bodies currently participating.

How does Health Canada have the authority to dictate to international certification bodies the time to audit, and the fees they should charge?

From what I've heard, the largest increase seems to be for small companies.
For mine, it nearly tripled the cost and duration. I've heard about similar increase from a few other people.

Same here. We are not officially on the program yet, but from the quotes I've got so far, the cost is approximately triple what it was to maintain our ISO13485/CMDCAS certification.

 

[mihzago]

The change was made to the MDSAP Audit Time Determination Procedure back in August, but it was just recently "officially" announced by HC. HC is listed as a change author, but I imagine this had to be approved by all Das.

see, MDSAP AU P0008.005: Audit Time Determination Procedure (PDF - 141KB) (broken link removed)

 

[Mark Meer]

The change was made to the MDSAP Audit Time Determination Procedure back in August, but it was just recently "officially" announced by HC. HC is listed as a change author, but I imagine this had to be approved by all Das.

Well, that quells my cynicism somewhat!

I'm glad that someone finally realized how absurd the mandated audit times were for small organisations.

..but you are saying that even with this change you are still paying approximately 3 times more? (all the quotes I got were before August so they were presumably going by the original time calculations)

 

[Mark Meer]

Reviving this thread, as the Canadian compliance deadline looms closer...

Curious:

1. Is anyone having concerns about meeting the Jan.1,2019 deadline?
2. Is anyone doing a cost/benefit, and considering just pulling out of the Canadian market altogether?

As I recall expressing elsewhere on this forum, I suspect Health Canada may realise that a significant portion of the medical-device establishments will be unable to meet the deadline, and will probably have to extend the deadline?

I'm curious how others see this playing out... Will HC extend deadline? Will many companies pull out of Canadian market? Will there simply be a bunch of non-compliant companies come Jan.1/2018 selling in Canada?

 

[Mark Meer]

Just under a year ago, only 7% of MDL manufacturers had signed on to be audited for MDSAP (and hence on-target to meet Health Canada's Jan.1,2019 deadline) according to Emergo.

Anyone have any idea what the estimates are now? I suspect the auditing organizations' resources are being taxed to the limit at this point...

 

[mihzago]

I just heard that BSI is at full capacity and does not schedule any more audits this year.