Regulatory Open Forum

I am working with a foreign manufacturer who has a cleared class II medical device (including electronic components). They created a US entity to become their initial importer in the US. Both the foreign and US entities are registered with the FDA.

As this is a large equipment, they would prefer to ship DIRECTLY to their customer in the US (to reduce shipping cost and time). Their customers are generally hospitals that are not registered with the FDA. They don't ship frequently (no device inventory!) and will only ship the equipment to the same facility once, but may have multiple shipments afterwards for the consumables that are used with the equipment.

1) Is it possible to ship to the end user?

2) If so, who is considered the initial importer?

3) If it is the US entity of the company, how is it documented that the destination address is different from the address of the initial importer?  (initial importer has a facility/address in the US, but no warehouse capability)

Any example, recommendations that would help us figure out how to make sure that we remain compliant, while facilitating the process will be helpful. 

Note: one DICE personnel has told me that any one who first takes possession of the equipment is considered initial importer and must register with the FDA. This does not seem to be realistic. Another agent made reference to user the terminology of "non-registered importer", but it is not clear where / how is this documented and used in the shipping documents. Because of their type of equipment, they will use the FDA form 2877.

Thank you

------------------------------
Catherine Gloster, MSc., RAC
Santa Barbara CA
United States
------------------------------

Original Message------

I am working with a foreign manufacturer who has a cleared class II medical device (including electronic components). They created a US entity to become their initial importer in the US. Both the foreign and US entities are registered with the FDA.

As this is a large equipment, they would prefer to ship DIRECTLY to their customer in the US (to reduce shipping cost and time). Their customers are generally hospitals that are not registered with the FDA. They don't ship frequently (no device inventory!) and will only ship the equipment to the same facility once, but may have multiple shipments afterwards for the consumables that are used with the equipment.

1) Is it possible to ship to the end user?

2) If so, who is considered the initial importer?

3) If it is the US entity of the company, how is it documented that the destination address is different from the address of the initial importer?  (initial importer has a facility/address in the US, but no warehouse capability)

Any example, recommendations that would help us figure out how to make sure that we remain compliant, while facilitating the process will be helpful. 

Note: one DICE personnel has told me that any one who first takes possession of the equipment is considered initial importer and must register with the FDA. This does not seem to be realistic. Another agent made reference to user the terminology of "non-registered importer", but it is not clear where / how is this documented and used in the shipping documents. Because of their type of equipment, they will use the FDA form 2877.

Thank you

------------------------------
Catherine Gloster, MSc., RAC
Santa Barbara CA
United States
------------------------------

This is what we were advised by FDA in 2014 when a similar situation arose:

The Hospital is not required to register by FDA, because it is only an "Importer", not an "Initial Importer". For this shipment, there is no Initial Importer. As long as the Hospital is identified on the manufacturer's FDA database listing as an "Importer" for the device, all the FDA requirements have been met.

The Hospital does not meet the definition of "Initial Importer" because it is the end user of the device. It has not imported the device in order to "further the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user" – these words are included in the FDA definition of Initial Importer.

The other advice we were given by FDA at the time was that FDA is interested in the device itself, and not the invoice. In other words, in so-called 'triangular' shipping arrangements, where the device is sent to one entity, but the invoice is sent to a different entity, the obligations of Initial Importer or Importer fall on the entity that receives the device, and not the one that receives the invoice.

Of course, depending on who you ask at the Agency, you probably will get different answers, but our client negotiated this particular issue in this way for several years.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 10-Oct-2019 03:00
From: John Beasley
Subject: Foreign manufacturer and direct shipment to customer

Hello Catherine,

If you would like, contact me and i can share a very similar experience with you.

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

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Original Message------

I am working with a foreign manufacturer who has a cleared class II medical device (including electronic components). They created a US entity to become their initial importer in the US. Both the foreign and US entities are registered with the FDA.

As this is a large equipment, they would prefer to ship DIRECTLY to their customer in the US (to reduce shipping cost and time). Their customers are generally hospitals that are not registered with the FDA. They don't ship frequently (no device inventory!) and will only ship the equipment to the same facility once, but may have multiple shipments afterwards for the consumables that are used with the equipment.

1) Is it possible to ship to the end user?

2) If so, who is considered the initial importer?

3) If it is the US entity of the company, how is it documented that the destination address is different from the address of the initial importer?  (initial importer has a facility/address in the US, but no warehouse capability)

Any example, recommendations that would help us figure out how to make sure that we remain compliant, while facilitating the process will be helpful.

Note: one DICE personnel has told me that any one who first takes possession of the equipment is considered initial importer and must register with the FDA. This does not seem to be realistic. Another agent made reference to user the terminology of "non-registered importer", but it is not clear where / how is this documented and used in the shipping documents. Because of their type of equipment, they will use the FDA form 2877.

Thank you

------------------------------
Catherine Gloster, MSc., RAC
Santa Barbara CA
United States
------------------------------

I have the same questions, except I know initial importer is responsible for complaint handling, MDR reporting.   Is your US office doing that? Are they competent and trained for it?

For anyone else using this model (direct shipment to hospitals or HCPs from a foreign manufacturer, how are you approaching requirements for import or distribution licenses required by states, if at all.
 
Would really love feedback on this.

Thanks!




------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 09-Oct-2019 13:44
From: Catherine Gloster
Subject: Foreign manufacturer and direct shipment to customer

I am working with a foreign manufacturer who has a cleared class II medical device (including electronic components). They created a US entity to become their initial importer in the US. Both the foreign and US entities are registered with the FDA.

As this is a large equipment, they would prefer to ship DIRECTLY to their customer in the US (to reduce shipping cost and time). Their customers are generally hospitals that are not registered with the FDA. They don't ship frequently (no device inventory!) and will only ship the equipment to the same facility once, but may have multiple shipments afterwards for the consumables that are used with the equipment.

1) Is it possible to ship to the end user?

2) If so, who is considered the initial importer?

3) If it is the US entity of the company, how is it documented that the destination address is different from the address of the initial importer?  (initial importer has a facility/address in the US, but no warehouse capability)

Any example, recommendations that would help us figure out how to make sure that we remain compliant, while facilitating the process will be helpful.

Note: one DICE personnel has told me that any one who first takes possession of the equipment is considered initial importer and must register with the FDA. This does not seem to be realistic. Another agent made reference to user the terminology of "non-registered importer", but it is not clear where / how is this documented and used in the shipping documents. Because of their type of equipment, they will use the FDA form 2877.

Thank you

------------------------------
Catherine Gloster, MSc., RAC
Santa Barbara CA
United States
------------------------------