Localization Issues

Last month Serbia changed its localization so that The Instructions for Use and labeling of medical devices must be written in the Serbian language. There was no grace period for this change, it was effective immediately. Conversely, Korea has also indicated that their localization is changing. Korean Instructions for Use and a Korean Label with regulatory information is now required. However, Korea has given a grace period to manufacturers until November 2013. At that point, the absolute deadline will be re-evaluated.

Manufacturers need a great deal of time to react to localization changes. There is a cost associated with the translation of the Instructions for Use and labeling. Each business must evaluate to see if the sales into the country justify the cost of the translation. Then, translation vendors must often be engaged to perform the translations, which can take months. The native language labeling can also cause a logistic nightmare, as often new finished good numbers are required to differentiate the native language labeling.

I understand that countries are trying to make medical devices safe for their citizens by providing instructions in their native language, but these types of decisions must be tempered with an appropriate grace period. Otherwise, they will create a situation where their citizens are deprived of medical devices that are necessary for their health, as devices without native language translations available will be blocked from sale into their country. Korea and Serbia are added to the increasing list of countries that are asking for native language localizations and labeling. Manufacturers must plan their businesses for increasing language and labeling requirements.