3 ms·
The device is registered in Canada and I found that information [0] : >For all devices except Class I, implement an ISO 13485:2016 under the Medical Device Sin
by seren 7y ago
The device is registered in Canada and I found that information [0] :
>For all devices except Class I, implement an ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP) compliant quality management system, which includes the specific requirements of the CMDR. ISO 13485 certification, used to demonstrate compliance with European regulations, does not meet Canadian requirements. Updates to the existing procedures, or new procedures, must be implemented.
So it seems you don't need to implement post market surveillance for a class 1 device or having a complaint handling unit.
[0] https://www.emergobyul.com/resources/canada-process-chart https://www.emergobyul.com/resources/canada-process-chart