MDL/MDEL private label process

#1
I want to make sure I understand the process, so please correct me if I'm wrong. This relates to a class 2 medical device.

We want to private label a new class 2 device from a manufacturer in China. They are focused on the US market and are awaiting FDA approval. We want to cover the Canadian market. So based on my understanding of the licensing in Canada, this is the process that we need to follow:

1. Original manufacturer applies for MDL license, which we will help them with.
2. Once they get an MDL license, we will apply for our own MDL private label license.
3. Once we have our MDL license, we can apply for an MDEL permit to be able to distribute/sell it.

Am I missing anything, or is this the correct process to follow?

Would appreciate any advice and feedback. Thanks.
 
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DannyK

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#2
The manufacturer must have an MDSAP certificate that includes the Canadian requirement.
If you an MDL license, you do not need an MDEL.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#3
Without any other regulatory approval, I don't think you qualify for Interim Order for Covid approval.
 
#4
The manufacturer must have an MDSAP certificate that includes the Canadian requirement.
If you an MDL license, you do not need an MDEL.
Thanks, Danny for the clarification. I'm waiting to find out if they have MDSAP. I know they are waiting on FDA approval, so I assume they have something. I think I saw in one of your other forum posts you're based in Montreal? We are too. Are you taking on any consulting clients? (Can't PM yet).

Without any other regulatory approval, I don't think you qualify for Interim Order for Covid approval.
I haven't heard of Interim Order for Covid. I'm curious when you said "other regulatory approval", was this referring to other countries like FDA approval or specific to Canada? Thanks for taking the time to reply, I appreciate it.
 

DannyK

Trusted Information Resource
#5
Hi v!ktor, I am taking on new clients and you can find me on LinkedIn.
I work with many virtual customers. Most of the suppliers from Asia do not have MDSAP unless they have targeted Canada as an important market.
I work with distributors that bring in the devices and become the "manufacturer" and I help them with ISO 13485:2016 and mDSAP so that they can market the products in their name.
This process has worked well and is cost efficient for the Canadian distributors.
Danny Kroo
 

DannyK

Trusted Information Resource
#8
Hello everyone,

Quick question:

Can I have MDEL, DEL, and EL with one company with the same address?
If you distribute medical devices you can have the MDEL,
DEL is for drug establishment license.
I work with companies that have MDEL and DEL.
I am not quite sure what EL stands for.
 
#9
Thanks Danny. EL is for Establishment Licence mainly for NHPs or natural health products.
The companies that you worked with have MDEL and DEL with the same address right?
 
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