Compliance documents for class II medical products
My listing has been taken by Amazon team in Canadian marketplace stating that it falls under Class II medical device and i need some compliance documents for it. My manufacturer in China has EC,FCC and ROHS which are the compliance documents in some other marketplaces. My question is can any of these documents be used as compliance documents in Canadian marketplace also? Because getting a MDL is a really expensive process for a small seller like me. There is another listing on Amazon for same product with ASIN B0F3VVQL1B , i am not sure if this one has compliance documents submitted or not? The ASIN for my listing is “BOFBS8KFW8” .
Compliance documents for class II medical products
My listing has been taken by Amazon team in Canadian marketplace stating that it falls under Class II medical device and i need some compliance documents for it. My manufacturer in China has EC,FCC and ROHS which are the compliance documents in some other marketplaces. My question is can any of these documents be used as compliance documents in Canadian marketplace also? Because getting a MDL is a really expensive process for a small seller like me. There is another listing on Amazon for same product with ASIN B0F3VVQL1B , i am not sure if this one has compliance documents submitted or not? The ASIN for my listing is “BOFBS8KFW8” .
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Seller_LBNcwL9dKwXun
Those documents may work for your MDL application, but you will be required to apply for MDL and receive certification for the device before being able to legally sell it in Canada again - there is no cheap work around.
