Where to start for MDSAP for Canada?

[SGquality]

We are an ISO 13485 certified organization and would like to export our US Class II medical device to Canada. Could you please help me where do I start with regards to Health Canada and MDSAP requirements - I seem to be overwhelmed.

Thanks in advance

 

[med_cert]

We are an ISO 13485 certified organization and would like to export our US Class II medical device to Canada. Could you please help me where do I start with regards to Health Canada and MDSAP requirements - I seem to be overwhelmed.

Thanks in advance

I believe you should start with MDSAP Audit Approach document and check Canada-specific requirements. Then you should update your quality management system to be compliant with those requirements. Of course you will need MDSAP Certification Body to perform an audit and issue a MDSAP certificate.

 

[SGquality]

Thanks med-cert. I am going through the MDSAP document that you referenced and also through the SOR/98-282 (CMDR). Does anyone have correlation table between 21 CFR Part 820 and CMDR?

 

[med_cert]

Thanks med-cert. I am going through the MDSAP document that you referenced and also through the SOR/98-282 (CMDR). Does anyone have correlation table between 21 CFR Part 820 and CMDR?

You can find some other discussions on this forum.. example: ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix

 

[Ed Panek]

We also made an RFQ for MDSAP to our notified body to help set expectations

 

[MedicalDevicesCanada]

I'd start by choosing the Auditing Organization - they are all listed here: fda gov/media/142182/download