As odd as it may sound, the FDA regulates initial importation as a type of statutory manufacturing activity. And from a pure statutory and regulatory standpoint, FDA does not prohibit manufacturers from outsourcing/delegating the execution of tasks for which the manufacturer is ultimately responsible. Now, we all know that the responsible initial importer is required to be registered and to establish applicable aspects of FDA's Part 820 quality system requirements. But the registration and quality system obligations for the third party to whom activities are delegated can be less clear. Specifically, the FDA's establishment registration and quality system requirements statutorily apply to anyone who is engaged in the manufacture (see first sentence of this post) of finished devices, among other triggering engagements. We would need to see precisely which tasks are being delegated by the initial importer (e.g., complaint handling) in order to make a final determination about the registration and quality system requirements (if any) that might apply to the third party.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 02-Oct-2023 13:47
From: Anonymous Member
Subject: Initial Importer
This message was posted by a user wishing to remain anonymous
Can initial importer activities such as MDR reporting be contracted out to a third party if our QA department is stretched thin?