Medical Device Labeling Requirements - EN:980:2008

L

LQ. Fanny Lozano

#1
Hi Coves!!

Requesting your help with the following: We are pretending to submit a medical device in Thailand which is sterilized with Ethylene Oxide, and according to the BS EN:980:2008, the symbol "STERILE / EO" must appear on the labelling of the product.
I would like to know if the "STERILE / EO" symbol must be placed in the collective box too, as in the primary package label.

Thanks a lot for your information! Cheers :)
 
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A

Adele

#2
BS EN:980:2008 does not specify the location of the symbol. Typically it is national regulations that define the location of symbols so you will have to check withthe Thai FDA. For example, the MDD specifies a hierarchy of where symbols should go but you may want to place the symbol in additional places based on risk management.
 
M

MIREGMGR

#3
"Pretending"? :)

To answer your original question, whatever the Thai minimum requirement may be, I think it's generally considered to be "best practice" in most countries that the labeling of the shipping box (i.e. collective container of some number of individual units, perhaps 6 or 10 or 25, etc.) should be equal to that of the individual units except of course for the quantity indication, so that the various persons that handle the product during the distribution process and at the end-user location have full information available regarding what product they are handling.
 
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