Exporting to Canada and MDSAP

#1
We export a class II medical device into Canada. We are current on their MDALL but because of COVID-19, we are having issue with getting an auditor to complete our MDSAP certification audit. So far we have a schedule date of March of 2021. We did have CMDCAS and are ISO 13485 compliant . Does anyone know if Canada would still allow my device to be sold in their country? I heard that MDSAP compliance in Canada was still voluntary.
 
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yodon

Staff member
Super Moderator
#2
Pretty sure it's not voluntary! You might check with Health Canada - they may offer some allowances due to the pandemic and general issues with scheduling MDSAP audits.
 

Chrisx

Involved In Discussions
#3
We purchased a company that did not have MDSAP and has a Canadian Device License. Health Canada sent me a survey in the last few weeks, where I had to indicate our date for a scheduled MDSAP audit. They acknowledged receipt of the survey and would await our MDSAP certificate. I would recommend contacting Health Canada and not waiting for the device license to expire.
 

Mark Meer

Trusted Information Resource
#4
As of 2019, MDSAP is required to sell class II and above medical devices in Canada.
However, Health Canada has announced some accommodations for COVID, but I think it's mainly with respect to allowing remote audits.
There is an email contact on the linked page for contacting Health Canada with inquiries re: COVID and MDSAP.

...and as Chrisx recommends, don't let the license expire, or you'll have to re-apply for a new one. ;)
 

RA_QA_Expert

Involved In Discussions
#6
Thank you for the information. I sent an email to Health Canada yesterday . I appreciate the advice.
Hi,
please, let us know the feedback from HC.

MDSAP certificate is mandatory for all manufacurers (except class I) since January 1, 2019. If you imported your medical devices wthout MDSAP cert. to Canada after this date (and before COVID19 pandemic), it is violation of Canadian law anyway.

Thank you and good luck
 
#7
Hi,
please, let us know the feedback from HC.
Well so far , they have said that we should probably let our licenses expire. We are still going back and forth with them. We are trying to get some sort of verification from our auditor that we passed the first stage audit to send as proof of our commitment to the MDSAP process.
 

Edward Reesor

Trusted Information Resource
#8
Canada lost access to a lot of foreign medical devices after MDSAP became mandatory on 01 January, 2019. The following is an except from the Health Canada website (see below). They did numerous modifications to assist in the streamlining of the process, but MDSAP is the only process Health Canada accepts. There have been several discussions here on the best way of dealing with it. Some companies have asked MDSAP certified companies (i.e. their distributors with HC licenses of their own) to add their devices under their MDL's.

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