...While the goal of this program is to improve medical device safety...
Is that the goal?
From their
original announcement:
...Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits...
- "...allows regulatory agencies to efficiently leverage resources..."
Perhaps Health Canada may save some money, but I'd like to see the estimates. How is surveying MDSAP compliance cheaper than CMDCAS?
- "...reduce regulatory burden on industry..."
Riiight... So a more than doubling of audit time each year, and tripling of cost is "reducing regulatory burden"?
- "...without compromising public health..."
As Edward Reesor points out, the outcome appears to be the opposite. Either costs will increase (as companies increase their prices to offset this added cost), or access is reduced (as some companies simply opt to leave the Canadian market altogether).
- "...more aligned and consistent technical requirements..."
What was wrong with ISO 13485/CMDCAS in this respect? I don't believe that system had any inconsistencies that MDSAP remedies.
...I fail to see how it will improve over the existing 13495, 14971 and the previous CMDCAS system (all audited by third parties), especially when you compare it to the root causes of medical errors in general.
Exactly.

Slightly off-topic: but I'd
love to see some hard data here with respect to the effects of increased regulation on public safety. Specifically: Can it be demonstrated that the rate of adverse incidents declines
(a) Above any historical trend prior to implementation of the regulations
(b) When adjusted for any increased sales & use of devices
(c) Taking into account root-causes the regulations are intended to address
My gut tells me we are at the point of diminishing returns...