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.
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.