What steps do you take to terminate a product which was licensed for sale in Canada

Jane's

Jane's

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This is the requirement from HC site:

The manufacturer must inform the regulator within 30 days after discontinuing sale of their medical device in Canada, in order to cancel the licence.
Click to expand...


Did anyone have any first hand experience with discontinuing product which was licensed for sale in Canada. I was wondering specifically if you would obsolete the product technical documentation right away or would you wait the lifetime of the device, or.. ? How about other countries, would you have to inform them right away of your product being terminated for sale in Canada or could you wait the next registration cycle to inform them.

Many thanks in advance.
 
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Y

yodon

Leader
Super Moderator
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Sorry, can't answer your question; it's a good one and I do hope the conversation continues. I expect this will come up more as MDSAP is soon to be a requirement for Canada and I'm guessing some companies will opt out.
 
Jane's

Jane's

Involved In Discussions
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Thanks, yodon. I am hoping to get some ideas from folks too. Let's wait and see. :cfingers:
 
Jane's

Jane's

Involved In Discussions
Re: What steps do you take to terminate a product which was licensed for sale in Cana

One belated find - there is a HC guidance on discontinuing drug (attached). Seems to me that's all we have as a starting point.
 

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S

snoopy2017

Re: What steps do you take to terminate a product which was licensed for sale in Cana

The same question came up at my previous medical device company. Just inform Health Canada as per the regulations. I hope this helps.
 
S

snoopy2017

Re: What steps do you take to terminate a product which was licensed for sale in Cana

Based on my experience with the E.U, we would keep the Technical File even after we stop manufacturing. We still retain the license but you don't have to make the product. I am not sure about informing international regulatory bodies if you no longer sell the device in Canada.
 
Jane's

Jane's

Involved In Discussions
Re: What steps do you take to terminate a product which was licensed for sale in Cana

It helps, thank you.

If anybody has experiencing with terminating devices sold internationally, I would appreciate their feedback as well.
 
Edward Reesor

Edward Reesor

Trusted Information Resource
Re: What steps do you take to terminate a product which was licensed for sale in Cana

I would notify Health Canada as per policy (as soon as possible in case there are delays, however I have found Health Canada to be surprisingly fast in processing our licensing needs).

That being said I would continue with the documentation for the lifetime of the device (and beyond just in case an end-user has stores of it and needs assistance with disposing/processing the remaining items, depending on the nature of the item you are referring to).
 
Jane's

Jane's

Involved In Discussions
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Thanks for your reply. I was hoping that is sufficient and planned to do the equivalent. My main remaining dilemma is whether to inform the international regulatory authorities, considering that our termination was business driven, not because there was something wrong with the device and i was hoping to not inform them, and to just not renew the license next time.
 
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Jane's

Jane's

Involved In Discussions
Re: What steps do you take to terminate a product which was licensed for sale in Cana

i just noticed a typo in my previous reply and i see i have no ability to edit old posts. Doesn't the admin know that people who frequent his or her forum are OCD. :D
 
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