Health Canada Field Action/Recall MDR Requirements

[jkc3usc]

Company initiated a recall on some mislabeled product. They are registered in CA but no affected product was distributed in CA. Do I still need to fill out a medical device recall form even though there will be no action taken in CA?

Filed an MDR with health CA and stated no product was located in CA so no action would be required? Is that substantial enough

 

[supadrai]

I'm not sure it's entirely clear that reporting to Health Canada was required but now that you've filed the initial report, you will probably also need to file the final report.

https://www.canada.ca/content/dam/h...t-rapport/gui-0054_recall-retrait-doc-eng.pdf

I'm just going from the information from the link above and don't have personal experience with MDR in Canada. But you're in the system now if you've filed something so it would be best to see it through because otherwise it will be open in their system and cause you a problem down the road.

 

[SK13485]

I clearly don't understand your story. If the products are not sold/distributed in Canada,a health canada recall is not required. But a recall will be required in the region where the mislabeled product is sold or distributed. I believe a MDR is also not required in this case. Please see the criteria for Health Canada MDReporting.

Since you chose to report it to Health Canada via MDR, you might need to wait for their reply or contact them through their email. I hope this answers your question.

 

[RA Guy]

No recall notification is required if affected product was not manufactured in, sold in or imported into Canada. Now that you've sent a notification you should be contacted by the inspectorate. The assigned officer will help you resolve the closure if the notification was not necessary.

You mentioned MDR. If you mean a report similar to the FDA Medical Device Report, its called MPR (Mandatory Problem Reporting) in Canada. This type of report is required for incidents that involve actual or potential death or seriuos injury. If the event(s) happened outside Canada, but the product is sold ino Canada, you would only need to report if the manufacturer or a foreign regulator determined corrective action is required as a result of the incident.

Alternately, you can follow up with the appropriate regional office (based on your geographic location) to resolve. The contact list is here:

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

In case you were not aware, here is a trove of information on post market reporting issues:
Medical Devices - Canada.ca

 

[jkc3usc]

So since the affected product is not in that country I still think they need notification? The product is registered in CA. Action was taken in the specific countries that product was located.

So if a product is registered but affected product is not in that country no notification is necessary?

 

[RA Guy]

For a recall, no, you do not need to notify Health Canada if no affected product was manufactured, importer or sold in Canada.

Here are the Canadian regluations pertaining to recall:

Medical Devices Regulations

Here is an expansion on the policies:

https://www.canada.ca/en/health-can...-health-product/drugs/recall-policy-0016.html

Please note Section 5.0 of the policy doument where is states:

It is the policy of the Inspectorate to verify that recalls of health products in Canada are conducted and reported in accordance with the Act and the Regulations.
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The way I understood your description of the issue is that no affected product was ever in Canada, therefore there is nothing to recall in Canada, therefore there is no need to report to Health Canada.

 

[supadrai]

Could the product have made it to Canada through another distribution channel?

 

[RA Guy]

Supadrai, I don't understand the question.

Your original post states the "no product was located in CA" so that's the basis of my original response and futher responses. Your original post also states that you formally notified HC that no product was in Canada.

 

[supadrai]

Supadrai, I don't understand the question.

Your original post states the "no product was located in CA" so that's the basis of my original response and futher responses. Your original post also states that you formally notified HC that no product was in Canada.

Hi RA Guy, I'm not the OP. I was just raising a question.

Is it possible that someone re-exported the product to Canada from another jurisdiction. But I think that importer would need a license also and OP would be aware of such a license even if not aware of any particular shipment to CA.

And if OP wasn't aware of any shipment of their product, could they still be held responsible.

This situation has come up for us, not in Canada and not with respect to any post-market. But our products have ended up places we didn't intend them to go.

 

[RA Guy]

Apologies supadrai.

You are correct that Importer has a role and responsibilites and ultimately the manufacturer has primary responsibility for what it or its licenced agents do on their behalf and how post market reporting is managed.