Consider the regulatory requirements AND the user safety, risk, and usability requirements.
Secondarily, consider the marketing / product presentation wishes and the operational efficiency wishes.
You can produce separate labels for products being shipped to different places.
You can produce one giant label that folds up small enough to attach to the package.
You can adjust the size of the packaging to accommodate the labeling.
You can put the minimum required information on the label and additional information inside the package and/or in an eIFU.
There is rarely a perfect solution.
------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------
Original Message:
Sent: 15-Nov-2019 13:13
From: Sorin Alb
Subject: Label Translations
Sorry, I thought this was about another thread.
Please ignore my previous message, if still available.
------------------------------
Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
Original Message:
Sent: 15-Nov-2019 09:29
From: Anonymous Member
Subject: Label Translations
This message was posted by a user wishing to remain anonymous
These are class 2 disposable medical devices, and they will be shipped globally. Although it is important to have good translations for every country, we are primarily concerned with Europe at the moment.
Original Message:
Sent: 13-Nov-2019 03:45
From: Spyros Drivelos
Subject: Label Translations
Please indicate the type of the product and the countries where you plan to ship the products
------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 11-Nov-2019 09:17
From: Anonymous Member
Subject: Label Translations
This message was posted by a user wishing to remain anonymous
I am looking for recommendations on best practices for including translations for labels that are to be shipped internationally. We currently only include 3-4 translations of the product description on our primary/base package label, and based on the sizes of our current labels, it seems unfeasible to include all the languages of the countries to which we sell. Some of the descriptions of our products can get quite lengthy, and having 20 different languages of a lengthy description on a 4 x 6 inch label seems impossible. Does anyone know of any possible solutions to this issue?