Manufacturer address on the label

monoj mon

Involved In Discussions
#11
In my opinion, yes, it will be appropriate.
When you are being audited make sure to highlight to the auditing entity upfront that the sites are quite far apart; be ready to welcome audit of both sites on the same occasion (maybe different days of the same week); and willing to accept extra charges caused by such separation.
Many thanks Ronen, much appreciated for your comment. So far, for our clients' audits, we are maintaining the process as you have explained. They are okay with that process and audited both the facilities on different days keeping in mind the need of the travel between the sites. As we are relatively new and also situated outside the USA, so far haven't experienced any FDA facility inspection. But we are getting us ready for any near future facility inspection by the FDA and get complied with all the regulations. I hope the USFDA is also okay with such kind of arrangement.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
I hope the USFDA is also okay with such kind of arrangement.
I can't speak for the FDA, but as noted above, I think that if you communicate to them the facts clearly, once you are notified of the upcoming inspection, you should be fine (provided that you already comply with the applicable registration and listing requirements).
 

monoj mon

Involved In Discussions
#13
I can't speak for the FDA, but as noted above, I think that if you communicate to them the facts clearly, once you are notified of the upcoming inspection, you should be fine (provided that you already comply with the applicable registration and listing requirements).
Thanks again Ronen. Yes, both the facilities are registered already. Facility A is registered as "Specification Developer" and identified as the "owner operator" while the Facility B is registered as "manufacturer".
 

Kim B

Starting to get Involved
#14
Hi - I have a question
We have a supplier who is a legal manufacturer of an accessory to our device and wants to remain the legal manufacture on the label, how would we list our name? Distributed by? How does this work with MDR for legal manufacturer with supplier and manufacturer? any thoughts or guidance would be helpful.
Thanks Kim
 

monoj mon

Involved In Discussions
#15
how would we list our name? Distributed by?
I think that would be a perfect solution, for both in EU and US. You can put your addresses distinguished by "Manufactured By" and "Distributed by".

How does this work with MDR for legal manufacturer with supplier and manufacturer?
To my understanding the above arrangement shall work in case of MDR also as you will need to provide the "manufacturer" information on the labels.

But, I would like to see if others have different opinion on this.
 

Kim B

Starting to get Involved
#16
I think that would be a perfect solution, for both in EU and US. You can put your addresses distinguished by "Manufactured By" and "Distributed by".



To my understanding the above arrangement shall work in case of MDR also as you will need to provide the "manufacturer" information on the labels.

But, I would like to see if others have different opinion on this.
 

Kim B

Starting to get Involved
#18
I think that would be a perfect solution, for both in EU and US. You can put your addresses distinguished by "Manufactured By" and "Distributed by".



To my understanding the above arrangement shall work in case of MDR also as you will need to provide the "manufacturer" information on the labels.

But, I would like to see if others have different opinion on this.

Second inquiry to this thread: if the supplier A is legal manufacturer of accessory and company B is final assembly of the system, can company B place their name on the main device? Will this work for MDR as well?
 

monoj mon

Involved In Discussions
#19
Second inquiry to this thread: if the supplier A is legal manufacturer of accessory and company B is final assembly of the system, can company B place their name on the main device? Will this work for MDR as well?
I think in the case of MDR more important will be whose CE mark is on the label. To my understanding you can put your name on the main device (kit!), but you will be responsible to maintain the technical documentation including the accessory from Comp. A if you put Comp. B's CE which (I guess) will be then issued for the main device including the accessory.
 
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