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Medical Device Labelling Regulatory Requirements - Barcode Formats

chris1price

Trusted Information Resource
#1
Hi guys

I have a few questions on barcodes:

1) Has there been any official regulatory developments regarding barcoding for Medical Devices in the past year?

2) What formats are different companies working with; Is any one format becoming more common? Has FDA made any decisions yet? (We use HIBCC in USA and GS1/GTIF in Europe)

3) Is anyone using 2D barcodes, and what formats are being used?

Chris
 
Elsmar Forum Sponsor
#2
There is something in Japan:

If you will use the address
http://www.e-gov.go.jp/en/doc/e-government.html
You can find the following document:
"Guidelines for Placing Standard Codes (Barcode Marking) on Medical Devices"
It is under draft status

Hope that it helped you
 

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Reiko Shiratori

#3
Additional information to Nissim's post:

I attached a sample format. I hope my English explanation is OK with you.

I think your Japanese Marketing Holders usually take care of these infomation. So this is just for your information.

Also 2D barcodes are acceptable in Japan, but my company has not used them yet.

Have a good day.:bigwave:


Reiko
 

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