Changing Manufacturer due to Spin Off

medtech_reg15

Registered
Hello, I am looking into the regulatory implications of changing the legal manufacturer (due to a spin off) with a focus on the US, EU, Japan and China. From what I see, this change would require the following (non-exhaustive):
  • US: Update Establishment Registration and Device Listing on FURLS within 30 days of change (SpinCo creates new account and adds devices in scope to Device Listing and RemainCo removes devices Device Listing). Get a new UDI and register it in the GUDID.
    • Is this correct and when can the SpinCo create this new account and add the devices to the Device Listing?
  • EU: Request Notified Body to issue new CE Certificate. Once new CE Certificate is received, SpinCo as new manufacturer can issue new DoC. SpinCo should also register as Manufacturer on EUDAMED.
    • Is there anytime specific timeline associated with this? Do most countries within the EU require the SpinCo to simply notify the Competent Authority and the timelines to do so depend on the country? As long as it is a simple manufacturer change (no design change, manufacturing site change), does that mean that there is no submission required fore review and approval?
  • Japan: register new Marketing Authorization Holder and submit new application for regulatory approval
    • Is there anytime specific timeline associated with this?
  • China: required to apply for new license (MDML)
    • Is there anytime specific timeline associated with this?
Also if the manufacturing site undergoes a name change during this transition (not actually site/manufacturing process change, only name change), would there be further regulatory implications?

Any insights and other things to consider are much appreciated!
 

medtech_reg15

Registered
We are still in the planning process and want to determine the point in time when FURLS should be updated. From your answer, it sounds like when the new legal manufacturer is operational and has an auditable (or already certified QMS in place). Correct? Even if the legal handover of ownership happens at a later point in time?
 
We are still in the planning process and want to determine the point in time when FURLS should be updated. From your answer, it sounds like when the new legal manufacturer is operational and has an auditable (or already certified QMS in place). Correct? Even if the legal handover of ownership happens at a later point in time?
Yes
 

medtech_reg15

Registered
I know the US does not use the terms Legal Manufacturer and Marketing Authorization Holder, but considering those concepts, is there a way to change your MAH on FURLS without changing your LM? For example (most likely not correct), can we say the Owner/Operator is the equivalent to the Legal Manufacturer which can be updated separately from the Official Correspondent which is the equivalent of the Marketing Authorization Holder. Or any other combination of terms where the LM and MAH are separately listed/managed on FURLS.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I also suggest a written and coordinated plan to establish risk controls and responsibilities during the transition.
 

EmiliaBedelia

Quite Involved in Discussions
MOST of your questions are dependent on how you are planning to transition the QMS. The legal ownership piece is not as important as the actual device related responsibilities (ie, design controls, QMS, and manufacturing) for the products.

1) Are you certified to ISO 13485/MDSAP? This should be one of your first actions - you will not be able to complete most of your proposed actions without having an updated certificate. It's unclear to me what exactly is going on with your QMS but you should consult with your NB about whether they need to audit or not. If you participate in MDSAP you may not even get audited by FDA.

2) Are you MDR certified yet? If you are only certified under MDD and do not yet have MDR certification, your NB cannot issue a new MDD certificate and you cannot issue a new DOC. Your NB can issue an amendment letter that will accompany your existing cert, and you can write a statement to document the amendment to the DOC. Be aware that if you have finished goods that are already labeled with the old company name, your NB may require you to sell them off within a defined period of time. You need to communicate with your authorized rep/importer as well to ensure that complaints, adverse events, etc are appropriately handled for existing products.

3) As for FURLS.... It is not entirely clear to me what the roles and responsibilities are for your spinoff/main manufacturer. Will the spinoff still be associated to the main company as "owner/operator", or is it an entirely different entity? Will the main company be retaining its FDA registration or will ALL device related activities be moving to the spinoff? These questions directly impact how you can register/list. Changing the manufacturer name without changing any other information is pretty easy to do in FURLS. However, if you want both the main and spinoff companies to be active, you will need 2 separate registrations (ie, pay the establishment registration fee for both entities).

The registration and listing roles (Specification Developer, Contract Manufacturer, etc) assigned in the Device Registration and Listing Module is where product related roles/responsibilities are indicated. IMO these are the roles that are most analogous to "legal manufacturer"/"MAH". Official Correspondent is not related to any of this - the contact information just needs to be correct and reach the right person if FDA emails you. I don't really think changing the Owner/Operator will help you either if you are entirely separating from the main company - maintaining the spinoff and main company registrations separately, or maintaining the spinoff as a subaccount of the main Owner/Operator will require to you manage 2 establishment registrations.

4) Minor point, but you may not require a new UDI. The GS1 GTIN allocation rules allow for the company prefix to be transferred to another company and for existing GTINs to be moved over. (https://ref.gs1.org/standards/genspecs/) You may need to unlock and update the GUDID record but changing the company name may not be an automatic trigger for a new UDI (refer to GUDID data elements reference table - https://www.fda.gov/media/120974/download?attachment).
 

medtech_reg15

Registered
Thanks for your in-depth response, @EmiliaBedelia!

At this point we are mainly concerned about the FURLS update. I asked the last question because there may be a scenario where another company is looking to buy the spin-off/divestment, but would like the current owner to remain the legal manufacturer for a certain period of time (via TSAs). Therefore, we believe that we would need to have the buyer as the Registration Holder/MAH and the current owner remains the LM. For the US, we do not know if the FDA differentiates between these two roles (i.e. if we could update one while keeping the other the same).
 

EmiliaBedelia

Quite Involved in Discussions
There is a way to do exactly what you are saying in FURLS.
The purchasing company would be the Owner/Operator. They will need to have their own FDA registration. When they edit their registration and listing information to add the new site, there is an option to add a registered site that is being added as a result of merger/acquisition.

"Owner/Operator" does not have anything to do with the actual manufacturing responsibilities related to the devices. Note that the 510k submitter/holder will never change - the 510k is a "point in time" and will not be updated. That's partly why the registration and listing information is key - the "manufacturer"/"spec developer" roles are tied to the 510k numbers, so they actually reflect who is doing what for each device.
 
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