Changing Manufacturer due to Spin Off

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!

You shouldn't register and list the device(s) until you are ready to be audited by the FDA. Are you ready?

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?

afakhraee said:

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?

Click to expand...

Yes