Dear Kazi
Ok, so from a regulatory perspective we need to be sure that you have a valid MA( market authorisation) IN India.
As per EU an logistics, there must be a shipment agreement in place indicating that the product will not be distributed in EU.
Have you spoken with the logistic company?
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Larisa Caplin
United Kingdom
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Original Message:
Sent: 20-Mar-2019 12:10
From: Sheemah Kazi
Subject: Distributor
Hi Larisa,
The distributor is in EU and the device is to be shipped to India.
Thanks,
Sheemah
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Sheemah Kazi
QA/RA coordinator
Concord CA
United States
Original Message:
Sent: 20-Mar-2019 05:40
From: Larisa Caplin
Subject: Distributor
Hi Kazi
Can I please ask what countries are they?
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Larisa Caplin
United Kingdom
Original Message:
Sent: 19-Mar-2019 14:36
From: Sheemah Kazi
Subject: Distributor
Hello Everyone,
Can you ship a medical device to your distributor in a country where it doesn't meet the regulation, solely to be shipped to another country where it meets the regulations?
Direct shipping isn't feasible because of the logistics.
Thank you for your advice in advance.
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Sheemah Kazi
QA/RA coordinator
Concord CA
United States
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