Sending disassembled medical device to Brazil to be re-assembled there

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evaedge

Hello everyone :)
I've been visiting the forum for a while and this is my first post. If this is not the right place for my topic, please kindly redirect me. :)

We manufacture Class I exempt devices in the US and sell them worldwide. We are registered with the FDA and have ISO 13485; devices are CE marked. Today my boss decides to send partially disassembled finished devices to Brazil, and have our distributor re-assemble them there. I don't know why he wants to do that, but it doesn't sound right to me...

First, the devices will be assembled, tested, labelled as per our procedures here at our plant. It will have a Certificate of Compliance. Then, some parts will be detached, for example, the caster base, the front door of a storage space, and possibly the monitor. The main device console inside where all the components and wiring are will not be disassembled. Those detached parts will then be packaged separately, but shipped with the device to Brazil (not our normal practice/packaging WI). Then our distributor will reassemble the devices and sell them in Brazil.

Is this a violation of GMP? How is it going to impact our ISO 13485 certification? I don't know if they are doing to save on shipping cost (I doubt it) or to avoid custom issues (not sure if the device has been registered in Brazil or not). I would be really appreciated if someone could advise on this issue. Thank you very very much! :thanx:

Eva
 

Marcelo

Inactive Registered Visitor
Hello Eva and welcome to the Cove!

We manufacture Class I exempt devices in the US and sell them worldwide. We are registered with the FDA and have ISO 13485; devices are CE marked. Today my boss decides to send partially disassembled finished devices to Brazil, and have our distributor re-assemble them there. I don't know why he wants to do that, but it doesn't sound right to me...

First, the devices will be assembled, tested, labelled as per our procedures here at our plant. It will have a Certificate of Compliance. Then, some parts will be detached, for example, the caster base, the front door of a storage space, and possibly the monitor. The main device console inside where all the components and wiring are will not be disassembled. Those detached parts will then be packaged separately, but shipped with the device to Brazil (not our normal practice/packaging WI). Then our distributor will reassemble the devices and sell them in Brazil.

Is this a violation of GMP? How is it going to impact our ISO 13485 certification? I don't know if they are doing to save on shipping cost (I doubt it) or to avoid custom issues (not sure if the device has been registered in Brazil or not). I would be really appreciated if someone could advise on this issue. Thank you very very much!

GMP compliance should be the least of your concerns.

If you send parts to Brazil to be assembled here, the distributor in Brazil turns into the manufacturer. So he will have to perform again all tests, including certification if necessary (which seems to be the case as it seems like a medical electrical equipment), before registering the device in Brazil.

One of the reasons for doing all this may be to make it quicker to sell in Brazil, or even to have the device be considered as a Brazilian device (which might help in public procurement).
 
J

JeffEM

Eva, 10+ years ago I sold components to electronics manufacturers and there was a significant difference in import duties on importing components that were assembled in Brazil verses finished product being imported to Brazil for sale.
 
E

evaedge

Thank you very much Marcelo and Jeff for your response!:)
Yes, I later found out that we were being asked to do this so our customer (distributor) can save significant duties and taxes if we ship as parts/components. What I'm planning to do is to indicate on the sales order that it is a customer requirement and we are providing assembly and testing procedure. Hopefully we won't get in trouble...
 
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