If a company (located out of Canada) sold some Class III medical devices (total less than 10 units)to Canada prior to Health Canada Approval, how can this company offset this fault? If this company applies the Medical Device License right now, how to deal with the black spot history.

If you mean you're just now applying for the license and therefore haven't received approval yet, I'd think it would be appropriate to initiate a voluntary recall for those ~ ten devices, and "un-sell" them.

I'd think that would be the best evidence that the company takes its regulatory obligations seriously, and should be given the approval even though it broke the rules.

You may have to lean on the customers to give back the units. No wink-and-nudge "just keep the unit and this will all blow over". I'd think you'd need to show not just lip service to the rules, but an actually effective recall.

If you have just now identified that some sales were made without having a license...did your system fail, or was it an intentional decision by someone to override or ignore the requirements because they wasn't as important as making sales?

In the former case, a documented system improvement and a disclosure report to Health Canada with an apology from top management might be a good approach. I don't know what Health Canada would do next, but I assume they'd respond with a mild admonishment to not do it again.

In the latter case, you have a problem. I assume you're back to the recall, but I don't know what Health Canada might want beyond that. If the Canadian market is important enough, maybe whoever made the decision to override the system should be disciplined, to get across that top management or the owners realize that legal compliance is involved.

If a company (located out of Canada) sold some Class III medical devices (total less than 10 units) to Canada prior to Health Canada Approval, how can this company offset this fault? If this company applies the Medical Device License right now, how to deal with the black spot history.

Sorry, but this seems to be an invitation for trouble :mg:

I would suggest that lot of legal implications may be involved so better solicit legal consultation.

It would be best to come clean on this before someone else finds out and reports it to Health Canada directly.

Call the items back. Our company has been selling FOBT in the United States for 35+ years and I just made appliocation for a Class III license. The Canadian version of the FDA is murder compared to ours.

Call the items back. Our company has been selling FOBT in the United States for 35+ years and I just made appliocation for a Class III license. The Canadian version of the FDA is murder compared to ours.

Welcome ken11356 :bigwave:

Thanks for your advise.

How long did it take to receive approval for selling to canada after applying?

Just curious -


What is the time frame in which these devices were sold?
Were they sold directly or via internet sales, through a distributor, etc.?
Was the sale through ignorance or willful disregard for HC rules?
Were these consumable devices or are they likely available for recall if such should be deemed necessary? (i.e. Have they been dispensed and used on patients?)
Does [did] the company actively advertise or market these products in Canada?
Do the products have FDA registration/approval?
If the products do have FDA approval, what was the date of the most recent FDA inspection of the facility? How does that date correspond with the dates of first and last sale of the device in Canada?

Literally dozens of companies were selling devices of other Classes in Canada before the present rules were adopted regarding "harmonization" through ISO 13485 registration. To my knowledge, Canada granted no "grandfather" exemptions, but neither did Canada force recall of products which may have been on distributor shelves or in consumer hands before the manufacturer achieved ISO 13485 registration.

Class III devices pose a risk to patients and generally are dispensed or used by physicians (heart valves, pacemakers, heart-lung machines, anesthesia devices, etc.) If these were purchased and dispensed by health care providers, how did they not know these devices were not Health Canada approved? Were they misled or did they buy with full knowledge?

All in all, this could be a very tricky and litigation-fraught situation. I agree with Ajit and would definitely counsel the seller/manufacturer to seek the advice of an experienced attorney BEFORE proceeding further. This is not a topic for easy resolution via a public forum.

Sorry I'm late to the discussion. I don't suppose these were Special Access devices under Health Canada's Special Access Program (SAP)? If you applied for and received authorization for them prior to import or sale, then you should be OK. The SAP allows in special circumstances the import and/or sale of non-approved devices (generally novel or custom devices or when no other treatment is available).

Otherwise, the I agree with everyone else: initiate a voluntary recall if you have not already done so.

Shawn

If a company (located out of Canada) sold some Class III medical devices (total less than 10 units)to Canada prior to Health Canada Approval, how can this company offset this fault? If this company applies the Medical Device License right now, how to deal with the black spot history.

Hi,

Just to let everyone know, Health Canada is waaaaayyyy behind on reviewing Class III medical devices. We submitted in January and are slated to be picked up (fingers crossed) for reveiw late August or September.

The last Class III device I submitted to Canada took 1.5 years. That included 2 sets of responses to questions they had. And the questions I answered were easy to answer questions so my response to them would only have added on 2 weeks to the entire review period.

The submission was sent July 2007, clearance was received January 2009.
Others I've sent before that didn't take as long.
And Class II's, they get licensed within a few weeks.

Our first submission was made in April 2009 and recd our rejection about 3 weeks later. we make a second submission the end of June 2009, i guess waiting 7 weeks is really nothing.