How to notify PMDA (Japan) on change of Legal Manufacturer?

Z

zhang126

#1
How to notify PMDA on change of legal manufacturer?

What documents are required?
 
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sreenu927

Quite Involved in Discussions
#2
Hi,

Is it only the name of the "Legal Manufacturer" or is it an entirely a different entity change?

For changes to notify to PMDA, you need use Form 16 and Form 20 (Unfortunately, I don;t have forms).

The documents depends on the classification of products that are registered with PMDA, such as floor plan, manufacturing process flow chart, ISO 13485 cert, etc..

The best way is to contact your Market Authorization Holder (MAH). He can advise you on the documents required and can do the notification with PMDA.

Regards,
Sreenu
 
Z

zhang126

#3
Thanks!

This time is name only.

Next time is like this: Company A in Germany acquired Company B in Sweden. The German Company will be the legal manufacturer for all PMDA approval (Class 3) of Comany B, but no physical change, i.e. no change of manufacturing site for the approved products in Japan. How to notify PMDA and what documents are required for this case? MAH:s of both companies in Japan are not competent and could not give a clear description on how to merge approvals and update the approvals (Shonin).
 

sreenu927

Quite Involved in Discussions
#4
Hi Zhang126,

Even if that case, the process is same.
After merger of A&B, I understood the new Company name would be C.
Then you will have all your licenses, ISO 13485 cert on the name of C with address in Germany.
With the required applications/forms, ISO 13485 Certificate, you can submit the docs to your MAH of the Company A (now called Company C). He will submit to PMDA and all product notifications will be changed in registry.

Then, from my view, MAH of Company B will be dissolved. or C may want to have two MAHs in Japan!!

Regards,
Sreenu
 
S

scrump0528

#6
I know this is an old post, but relevant to my current situation.

In the case of an acquisition scenario (Company B is bought by Company A and now will move manufacturing under Company A's legal entity), is it simply a notification of the change the PDMA.

This assumes all quality systems, manufacturing systems, etc. do not change only the legal manufacture.

Also, how long does this process usually take for approval of that change?
 
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