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We are a Canada based medical device manufacturer. Our FDA cleared IVD devices are manufactured by a contract manufacturer based here in Canada. The device is manufactured and shipped to use here in Canada. We sell and ship the device to distributors/customers in the USA. I was really hoping you someone could assist me with a couple of questions based on the New Device Registration and Listing Requirements
1. Our Contract Manufacturer in Canada is asking us for a list of our initial importers in the USA to complete their contract manufacturer listing with the FDA. As our Contract Manufacturer only ships the devices to us in Canada and does not ship to anyone directly in the USA, are they still required to provide this initial importer information in their FDA re-registration?
2. Many of our initial importers are our end user customers, for example hospitals and clinics. Do we need to include these in our list of initial importers with our FDA listing? Additionally, does this also mean that these end users/customers need to be registered/listed with the FDA?
I would really appreciate any help and assistance with these questions.
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1. Our Contract Manufacturer in Canada is asking us for a list of our initial importers in the USA to complete their contract manufacturer listing with the FDA. As our Contract Manufacturer only ships the devices to us in Canada and does not ship to anyone directly in the USA, are they still required to provide this initial importer information in their FDA re-registration?
2. Many of our initial importers are our end user customers, for example hospitals and clinics. Do we need to include these in our list of initial importers with our FDA listing? Additionally, does this also mean that these end users/customers need to be registered/listed with the FDA?
I would really appreciate any help and assistance with these questions.
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