MDR PSUR versus Canadian Summary report

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bill.Kal

Involved In Discussions
Hi Community

I am trying to figure out our post-market surveillance requirements for our IIa/IIb CE-marked (legacy devices) but in Canada (they also are on the market there already).
I have been reading the latest canadian guidance and I find no significant differences from MDR's PSUR. Since we already have that ready for our MDR submission do you think I could just change the compliance statement and submit the same document? Anyone has any experience/feedback from Health Canada after submitting a PSUR as a Summary Report? Or even better does anyone have any comments on the differences of the 2 documents?
Thank you all for the precious help
 
D

DannyK

Trusted Information Resource
The Canadian post market surveillance report does not have to be submitted to Health Canada, unless requested or unless the benefit/risks have changed significantly.
It will be verified by your MDSAP auditor.
Health Canada also asks for foreign risk notification.
There is a guidance document for foreign risk notification that you can combine with post market surveillance report.
 
B

bill.Kal

Involved In Discussions
DannyK said:
The Canadian post market surveillance report does not have to be submitted to Health Canada, unless requested or unless the benefit/risks have changed significantly.
It will be verified by your MDSAP auditor.
Health Canada also asks for foreign risk notification.
There is a guidance document for foreign risk notification that you can combine with post market surveillance report.
Click to expand...


--
thank you for the valuable feedback! If I understand correctly, what you are saying is that the Summary Report must be part of the periodic MDSAP audits and not a stand-alone independent and direct submission to the canadian authorities?
 
D

DannyK

Trusted Information Resource
bill.Kal said:
--
thank you for the valuable feedback! If I understand correctly, what you are saying is that the Summary Report must be part of the periodic MDSAP audits and not a stand-alone independent and direct submission to the canadian authorities?
Click to expand...

The Summary report and foreign risk notification can be requested during the MDSAP audit.
There is no direct submission to Health Canada. It can be requested by Health Canada.
 
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