Candian Medical Device - Same product, different name

R

rob_heg

#1
I am hoping someone familiar with the Canadian MDR can give me the proper steps to take to make sure we are good to go when our product is launched in Canada.

We have ISO 13485 and our Canadian Medical License. It is just one device, listed as [widget A]. Recently, we contracted with a distributor that is going to take our product to Canada, but they have re-branded it, calling it [widget B]. So the product is exactly the same, but just with a different name.

What are the steps I need to take to update our listing to show that the product to be marketed is called Widget B?
 
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DannyK

Trusted Information Resource
#2
Hi Rob,

When they re-brand the product, do they remove your company's name and address from the label?

If your company name and address are still on the device, you can just add the new brand and product code to your existing license. There is a fax back amendment form for nonsignificant changes.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_nonsigchng_fm_modnomimp-eng.php

If they want to remove our company name and address, you can either
1. private label the medical device for the distributor
2. distributor can apply for ISO 13485 CMDR Part 1 certification and then apply for the license.

Option 1 is cheaper and faster.

I have done this process many times. If you are interested, send me a private e-mail.
 
R

rob_heg

#3
Danny, that is great info. Thank you sooo much. Let me check with my team and I will get back to you will specifics.:thanx:
 
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