Medical Device Company US Importer/Distributer Status

G

Gaya123

#1
Hi all

We are a medical device company that manufactures class I exemp device.
We are working in 3 locations:
Site in israel - specification developer
Contract manufacturer in china
and office in USA which is registered as the initial importer
I would like to ask what the USA office can or can not do regarding
1. service process - repairs
2. Software upgarde
2. Refurbished devices

Thanks

Gaya
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi all

We are a medical device company that manufactures class I exemp device.
We are working in 3 locations:
Site in israel - specification developer
Contract manufacturer in china
and office in USA which is registered as the initial importer
I would like to ask what the USA office can or can not do regarding
1. service process - repairs
2. Software upgarde
2. Refurbished devices

Thanks

Gaya
Hi Gaya,

As far as I understand, this "US office", on top of being the registered importer, is an extension of the specification developer (its marketing arm), and as such --

Activity #1 falls under "reconditioning of multiple use devices", which is a somewhat grey area for years.

Activity #2 falls under either device changes or field corrective actions on behalf of the spec developer.

Activity #3 falls under remanufacturing of medical devices, which possibly repositions either the US office or the spec developer (or both, depends on the circumstances) as a full-scope medical device Manufacturer.

All of these activities are permitted for the US office, as long as the applicable requirements are met under the categorization I listed above.

Cheers,
Ronen.
 
G

Gaya123

#3
Thank you Ronen

Let's say that I will Registered the US office as a manufacturer
What do other changed will I have to do other then registration and labeling?
Can I register the USA facility both as importer and manufacturer?
Can this manufacturer can be defined as an extension of the Israeli facility being under the same QMS?

Thanks

Gaya
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Let's say that I will Registered the US office as a manufacturer
What do other changed will I have to do other then registration and labeling?
WRT to class I devices, all manufacturers are subject to the General Controls:

http://www.fda.gov/MedicalDevices/D...rview/GeneralandSpecialControls/ucm055910.htm

In general, for a class I (510k exempt) device these would be registration & listing, labeling and cGMP (QSR), unless it's also GMP exempt.

Can I register the USA facility both as importer and manufacturer?
I don't see a reason why not. The facility will be an Importer WRT the devices which are imported and distributed without significant change, and a Manufacturer WRT devices which they remanufacture (or otherwise manufacture).

Can this manufacturer can be defined as an extension of the Israeli facility being under the same QMS?
Yes, with one exception - obviously the importation activity can't be registered under an entity located outside the USA.

Cheers,
Ronen.
 
G

Gaya123

#5
Hi Ronen
Regarding repaired beeing made by the inporter:
according to NB-MED/2.1/Rec5

"A person sending a medical device for service or repair may or may not receive
the same item back. Often a manufacturer will immediately replace the device
with another of the same type in order that the user is not left without equipment.
Alternatively, the manufacturer may operate a pool of devices of the
same kind into which the repaired device is placed. The user may receive any
one of those ?pool? devices in return for the one he sent for repair. This procedure
does not necessarily mean that the replacement device has been fully refurbished,
even if it has been serviced or repaired and checked for proper
working order."

My understanding is that the importer can get a product from a customer and send him back a product from the pool. This is not a refurbish device and the importer can do that without being the manufacturer. Does this also acceptable in USA by the FDA?

Regards

Gaya​
(
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi Ronen
Regarding repaired beeing made by the inporter:
according to NB-MED/2.1/Rec5

"A person sending a medical device for service or repair may or may not receive
the same item back. Often a manufacturer will immediately replace the device
with another of the same type in order that the user is not left without equipment.
Alternatively, the manufacturer may operate a pool of devices of the
same kind into which the repaired device is placed. The user may receive any
one of those ?pool? devices in return for the one he sent for repair. This procedure
does not necessarily mean that the replacement device has been fully refurbished,
even if it has been serviced or repaired and checked for proper
working order."

My understanding is that the importer can get a product from a customer and send him back a product from the pool. This is not a refurbish device and the importer can do that without being the manufacturer. Does this also acceptable in USA by the FDA?

Regards

Gaya​
(
Hi,

NB-MED's apply only for the EC market.

As I mentioned in my first reply on this thread, repairs may fall under "reconditioning", an area in which FDA's requirements are not very clear and conduct is more an issue of voluntarily applying industry accepted practices. The web holds the relevant information so if you do some research you will understand what I'm talking about.

Real refurbishing falls under "remanufacturing", for which FDA has clearer requirements / guidance.

Cheers,
Ronen.
 
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