Generally it is possible to get an exemption to prevent a bunch of duplicate reporting in situations like this (where both the manufacturer and initial importer are technically required to report). Different direction, but in the past I had one for a plant in Ireland when we did all MDR decisions centrally in our US office. However, you do need to send in a request for this exemption to OSB, and sometimes they take a long time to process and grant them - in the meantime both sites should be filing under 803. To support your exemption request, you should be able to demonstrate that you have a process to get complaints to the right location (perhaps one that the importer forwards to the manufacturer) and a Quality Agreement between the 2 sites showing who is responsible for what.
Good luck!
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 17-Jan-2018 05:32
From: Rashmi Pillay
Subject: FDA Exemption of reporting
Hi,
Has anyone made an exemption to reporting responsibilities under Sec. 803.19 for an importer, where the importer is a subsidiary of the manufacturer
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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