Three Questions on Finished Medical Device Traceability, Labeling and Packaging

SGquality

Quite Involved in Discussions
#1
Sorry for asking so many questions -

  1. Is the "Country of Origin" needed to be mentioned on all packaging materials supporting a finished medical device ? We have a customer packagaing that mentions the Customers address in US but does not have specific reference to "Country of Origin". Under what circumstances if the "Country of Origin" required ?
  2. Being into plastic injection molding for medical devices, we assign a Lot Number for the weekly running of the products but the manufacturing date keeps changing based on the actual date olf molding. Is this practise acceptable to have the same Lot number with different manufacturing dates ? My gut says its fine but when I read the FDA definition of "Lot" I felt it to be not okay.
  3. We get printed product bags from the supplier and then we pack the product in it and put a sticker having batch details. Is the practise of affixing sticker with product detail acceptable in the US per FDA requirements ? I am asking this question as some countries do not allow stickets and want batch details to be overprinted.
Thanks in advance :thanx: :thanks:
 
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M

MIREGMGR

#2
Re: Question on finished devices

Is the "Country of Origin" needed to be mentioned on all packaging materials supporting a finished medical device ? We have a customer packagaing that mentions the Customers address in US but does not have specific reference to "Country of Origin". Under what circumstances if the "Country of Origin" required ?
You mention a US customer, so I'm answering for US requirements: all products imported into USA are required by US Customs and Border Protection (CBP) rules (note that CBP is not part of FDA) to be labeled on the product, or if not practical such as for a sterile medical device, on its immediate packaging, as to Country of Origin. When products are shipped in cases, it's normal practice to also carry this Country of Origin labeling on the case as well.

Being into plastic injection molding for medical devices, we assign a Lot Number for the weekly running of the products but the manufacturing date keeps changing based on the actual date olf molding. Is this practise acceptable to have the same Lot number with different manufacturing dates ? My gut says its fine but when I read the FDA definition of "Lot" I felt it to be not okay.
You can define a production lot how you want. Just be prepared to recall the entire lot if there is a problem such that a recall is required. Lot designation is to economically protect you, mostly.

We get printed product bags from the supplier and then we pack the product in it and put a sticker having batch details. Is the practise of affixing sticker with product detail acceptable in the US per FDA requirements ? I am asking this question as some countries do not allow stickets and want batch details to be overprinted.
Self-adhesive regulatory labels on bulk product bags are permissible when there is a sufficient justification for not regulatorily labeling the individual product units. There is no preference for printing on the bag as opposed to adhering a label to the bag, as long as the labeling method is effective.
 

SGquality

Quite Involved in Discussions
#3
Re: Question on finished devices

You mention a US customer, so I'm answering for US requirements: all products imported into USA are required by US Customs and Border Protection (CBP) rules (note that CBP is not part of FDA) to be labeled on the product, or if not practical such as for a sterile medical device, on its immediate packaging, as to Country of Origin. When products are shipped in cases, it's normal practice to also carry this Country of Origin labeling on the case as well.
So if the device is manufactured in US for a US customer, is it required to label "Country of Origin" ?
 
M

MIREGMGR

#4
Re: Question on finished devices

So if the device is manufactured in US for a US customer, is it required to label "Country of Origin" ?
Assuming the device will not cross any international borders, no.

But note that many devices made for US OEMs are exported to end users in other countries. Many other countries have adopted Customs regulations similar to the US one, i.e. a Country of Origin statement is mandatory.
 
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