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Health Canada to increase PMS requirements

Edward Reesor

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#1
Yesterday we were notified that Health Canada, in addition to making the MDSAP program mandatory by January 2019, has announced an intent to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada.

This appears to be a similar program that the EU imposed with the implementation of Rev4, which has resulted in some manufacturers withdrawing from the EU market, however the details are still being discussed.

I sense the irony in the tenfold increase in fees with MDSAP plus the additional PMS program fees being at odds with their announcements of increasing patient care through innovation.

I can only see more manufacturers and distributors leaving the Canadian market as a result.
 
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Mark Meer

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#2
...
I sense the irony in the tenfold increase in fees with MDSAP plus the additional PMS program fees being at odds with their announcements of increasing patient care through innovation.

I can only see more manufacturers and distributors leaving the Canadian market as a result.
Yup. My thoughts exactly. Health Canada policy makers seem to be somewhat myopic in this regard.

In their notice of intent, the "drivers for change" are listed as (to summarize):
1. Medical devices are increasingly complex.
I fail to see how this is relevant. If this is a legitimate justification for new regulation, it can be used for justification for just about anything!

2. International regulators are generating/using more real-world data and evidence.
So what? Seems to be a "because they're doing it" argument.

3. Pressure to align international regulatory frameworks.
Again, a "because they're doing it" argument. Unnecessary, IMO. If a manufacturer wants to sell a CE-marked product in Canada, can HC not just recognise that the product is already subject to requirements over-and-above what HC requires without having to mandate these additional requirements in their own regulations?

4. Desire to support integration of new technologies while maintaining patient safety.
As you point out, these policies may have precisely the opposite effect. Also, I fail to see how mandating annual reports helps achieve this...

It's a shame that there aren't some quantifiable metrics with which one could assess if increased regulation actually is net-beneficial. If there were, my (granted, cynical) prediction would be you'd find these policies have very little effect on actual patient safety and healthcare. In fact, it is probable - as you point out - that they actually have deleterious effects.

Seems to me a clear case of regulatory creep... :(
 
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