Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​My company has 510(k) clearance to market a medical device in the U.S. We are the 510(k) sponsor, specifications developer, and currently the sole manufacturer of the device.  We also have Shonin approval to market the device in Japan through our Japanese parent company.  Our Japanese parent is in the process of building a manufacturing site in Japan to sell this product in Japan only.

My question is whether we, as the U.S. company, need to register the Japanese manufacturing facility with FDA if the product manufactured there will only be sold in Japan.

Per U.S. statute, every person who owns or operates any establishment within any foreign country engaged in the manufacture of a device that is imported or offered for import into the United States shall register its establishment. That means that if said manufacturer's devices are not imported or offered for import into the United States, then that manufacturer is not required to register.

Hope this helps,

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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Jan-2018 15:02
From: Anonymous Member
Subject: Establishment Registration

This message was posted by a user wishing to remain anonymous

​My company has 510(k) clearance to market a medical device in the U.S. We are the 510(k) sponsor, specifications developer, and currently the sole manufacturer of the device.  We also have Shonin approval to market the device in Japan through our Japanese parent company.  Our Japanese parent is in the process of building a manufacturing site in Japan to sell this product in Japan only.

My question is whether we, as the U.S. company, need to register the Japanese manufacturing facility with FDA if the product manufactured there will only be sold in Japan.

​By the way, the aforesaid statutory requirement is further clarified by the corresponding implementing regulation at 21 CFR 807.40(a) stating that any establishment within any foreign country engaged in the manufacture...of a device that is imported or offered for import into the United States shall register such establishment.  Again this shows that the scope of these requirements is intended to encompass devices imported or offered for import.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Jan-2018 09:42
From: Kevin Randall
Subject: Establishment Registration

Per U.S. statute, every person who owns or operates any establishment within any foreign country engaged in the manufacture of a device that is imported or offered for import into the United States shall register its establishment. That means that if said manufacturer's devices are not imported or offered for import into the United States, then that manufacturer is not required to register.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 10-Jan-2018 15:02
From: Anonymous Member
Subject: Establishment Registration

This message was posted by a user wishing to remain anonymous

​My company has 510(k) clearance to market a medical device in the U.S. We are the 510(k) sponsor, specifications developer, and currently the sole manufacturer of the device.  We also have Shonin approval to market the device in Japan through our Japanese parent company.  Our Japanese parent is in the process of building a manufacturing site in Japan to sell this product in Japan only.

My question is whether we, as the U.S. company, need to register the Japanese manufacturing facility with FDA if the product manufactured there will only be sold in Japan.