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What steps do you take to terminate a product which was licensed for sale in Canada
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What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
What steps do you take to terminate a product which was licensed for sale in Canada
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  Post Number #9  
Old 9th November 2017, 12:44 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
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.

Last edited by Jane's; 9th November 2017 at 02:42 PM.

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  Post Number #10  
Old 9th November 2017, 12:47 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
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.
  Post Number #11  
Old 9th November 2017, 01:45 PM
Edward Reesor

 
 
Total Posts: 62
Re: What steps do you take to terminate a product which was licensed for sale in Cana

I believe there are more than a few organizations pulling away from the market. I know a few ceasing distribution in Europe because of the new MDR expectations. With many notified bodies dropping the program, many companies are re-thinking their plans.

I don't think there is a requirement to let them know about distribution outside of their jurisdiction. I would mention it at your next audit, detailing the steps you took to notify Health Canada as proof of your attention to reg's. For them to expect notification for all international markets outside of their jurisdiction would create quite the headache.
Thank You to Edward Reesor for your informative Post and/or Attachment!
  Post Number #12  
Old 9th November 2017, 02:05 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Good point.
  Post Number #13  
Old 9th November 2017, 02:27 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,211
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Quote:
In Reply to Parent Post by Edward Reesor View Post

With many notified bodies dropping the program, many companies are re-thinking their plans.
Do you know if there is publicly available information which NB's are voluntarily dropping from "the program"?
  Post Number #14  
Old 9th November 2017, 02:40 PM
Edward Reesor

 
 
Total Posts: 62
Re: What steps do you take to terminate a product which was licensed for sale in Cana

I know of a company that received a letter saying that AMTAC wasn't doing MDR as of January 2018 and I was in a webinar in July that stated that the number of NB's has fallen from 80 to 56 and was expected to drop even more. That's all I know of at the moment.
  Post Number #15  
Old 9th November 2017, 02:45 PM
Edward Reesor

 
 
Total Posts: 62
Re: What steps do you take to terminate a product which was licensed for sale in Cana

Found a list of NB's here. Because its broken up by country there may be a lot of overlap so its not easy to confirm that 56 value I just presented (above). I see that you can also search the list for withdrawn or expired NB's. Its a big list. If I'm misinterpreting the list, please let me know.

Last edited by Edward Reesor; 9th November 2017 at 03:02 PM.
Thanks to Edward Reesor for your informative Post and/or Attachment!
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