Brazil Medical Device Label Issues

E

evilchilli_420

#1
Hello,

I recently ran into an issue and need your help. I work for company X and we recently purchased company Y. We completed all registrations to X's name and the labels also indicate X as manufacturer. Unfortunately some of our Class I instruments are still engraved with Y's name but their labels indicate X as design control owner.

Is there a requirement that the engraved name on the device should be the same as the design control owner? We are having issues with Brazil customs and are unable to export the device.

Any help is appreciated.


Thank you,
N
 
Elsmar Forum Sponsor
F

fredson

#4
Hello,

I have with my Company a similar issue.
The Company (X) has an EU Headquarter, which is the legal manufacturer of some devices made in China ( by Company Y). The devices are imported from a third Company (Z) in Brasil. Y and Z companies are owned by X.
On the labeling appears:
- X as Manufacturer
- the wording "Made in China"

We are now experiencing increasing Problems with the custom for the Import of the devices.

Do we need to write "Made by Company Y for Company X, imported by Z"?

Any help is welcome!

Thanks,

Fredson
 
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