Edward Reesor
Trusted Information Resource
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.
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.