Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Background:

We are a US medical device manufacturer relocating our HQ to a new facility in a different state. We are ISO 13485:2016 and MDSAP Certified. We have our annual NB Surveillance Audit scheduled for about a month after we complete the relocation and resume production activities. As the Surveillance Audit is within 30 days of the final move date, our NB (SGS) is scheduling our one day Extension to Scope (to update the address on our cert) to fall within the Surveillance Audit. Our applicable MDSAP Jurisdictions are USA, Canada, and Australia. 

Question:

Are we fine to sell the devices we produce between our final relocation date and the Surveillance Audit? NB said Canada is the only MDSAP jurisdiction that cares about the address being updated which has to be completed within 30-45 days of our move. 

Hello Anon,

In most cases, there are some time frames allowing updates, notifications, and/or change to certain aspects such as changing facility locations.  It really depends on the regulatory region and specifics around.  In most cases, continuing sells of a product is allowed when changing facilities.  This of course has many documentation needs such as a Quality Plan, notifications, validations, change control, etc.  You may want to seek further advice specific to your situation, but the answer can be selling product can continue ensuring proper aspects are being met.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Aug-2023 16:22
From: Anonymous Member
Subject: Manufacturing Facility Relocating HQ

This message was posted by a user wishing to remain anonymous

Background:

We are a US medical device manufacturer relocating our HQ to a new facility in a different state. We are ISO 13485:2016 and MDSAP Certified. We have our annual NB Surveillance Audit scheduled for about a month after we complete the relocation and resume production activities. As the Surveillance Audit is within 30 days of the final move date, our NB (SGS) is scheduling our one day Extension to Scope (to update the address on our cert) to fall within the Surveillance Audit. Our applicable MDSAP Jurisdictions are USA, Canada, and Australia. 

Question:

Are we fine to sell the devices we produce between our final relocation date and the Surveillance Audit? NB said Canada is the only MDSAP jurisdiction that cares about the address being updated which has to be completed within 30-45 days of our move. 

The quality management system (QMS) requirements from Canada's CMDR, FDA's QS Regulation, and Australia's TG/MDR (embedded in its conformity assessment procedures) don't directly prohibit sales of devices after a facility relocation as long as the various QMS requirements (see Richard's great post) are properly addressed.  However, those requirements along with these jurisdictions' device premarket authorization requirements [like FDA's 510(k) requirements, its PMA amendment requirements, Canada's device licensing significant change requirements, and Australia's similar requirements] which are embedded by reference within the MDSAP paradigm may require waiting on sales of devices made at the new facility until corresponding premarket regulatory authorization is received.  This would generally be for higher-risk devices.  You also need to carefully adhere to any corresponding clauses in your contract with your MDSAP AO and/or your European Notified Body (NB) (I noticed you mentioned "NB" which is a concept generally unique to Europe).

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 06-Aug-2023 16:26
From: Richard Vincins
Subject: Manufacturing Facility Relocating HQ

Hello Anon,

In most cases, there are some time frames allowing updates, notifications, and/or change to certain aspects such as changing facility locations.  It really depends on the regulatory region and specifics around.  In most cases, continuing sells of a product is allowed when changing facilities.  This of course has many documentation needs such as a Quality Plan, notifications, validations, change control, etc.  You may want to seek further advice specific to your situation, but the answer can be selling product can continue ensuring proper aspects are being met.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 02-Aug-2023 16:22
From: Anonymous Member
Subject: Manufacturing Facility Relocating HQ

This message was posted by a user wishing to remain anonymous

Background:

We are a US medical device manufacturer relocating our HQ to a new facility in a different state. We are ISO 13485:2016 and MDSAP Certified. We have our annual NB Surveillance Audit scheduled for about a month after we complete the relocation and resume production activities. As the Surveillance Audit is within 30 days of the final move date, our NB (SGS) is scheduling our one day Extension to Scope (to update the address on our cert) to fall within the Surveillance Audit. Our applicable MDSAP Jurisdictions are USA, Canada, and Australia. 

Question:

Are we fine to sell the devices we produce between our final relocation date and the Surveillance Audit? NB said Canada is the only MDSAP jurisdiction that cares about the address being updated which has to be completed within 30-45 days of our move.