Health Canada Registration : Company and/or 3PL ?

fondantcookie

Starting to get Involved
#1
Hi everyone.

I'm hoping you can advise on another of my "I'm new to RA" related questions.

I work for a global medical device/IVD manufacturer. One of our sites is based in Canada and they currently use a 3PL warehouse facility in Toronto to support with storage and distribution of products within the Canadian market. Currently the 3PL supplier is registered with Health Canada independently.

With that being said, does our Canadian site need to register the 3PL supplier with Health Canada in any way or is the 3PL registration sufficient?

HUGE thank you in advance :)
 
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shimonv

Trusted Information Resource
#2
Hi fondantcookie,
If your CAN/CSA ISO 13485 certificate does not include the 3PL site I don't see how you can register them with Health Canada.
It seems to me that they are no different than other suppliers in your approved supplier list.
Let me know if I misunderstood you in any way.

Shimon
 

DannyK

Trusted Information Resource
#3
I am guessing that the 3PL site in Canada has a Medical Device Establishment License. that allows the to distribute product.

I do not believe the Canadian site needs to register the Canadian site with Health Canada. When you have your certification body audit, you may need to identify the 3PL company as a critical/significant supplier.
 
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