It used to be much easier to have an international device on the market that complies with the regulations of the multi-country international market. With a properly localized multi-language Instructions for Use, the regulations of most international countries were met with one finished good. However, international regulations are becoming increasingly complex. In addition, more and more countries have difficult labeling requirements that are specific to their country.
For many years China and Brazil have required a label that details the registration information for the product in their native language. These labels must be updated whenever the product is renewed, as they must display registration information including the product certification number. For a domestic registration in China, the registration number can change each time a new product is added to an existing certification. Depending on new part release schedules, this can happen every few months. Brazil also requires that their product registration information on a Brazilian Portuguese label. Both of these countries are emerging markets with high population basis. Most marketing departments make the decision to meet the requirements of these countries in order to break in to these larger markets.
Now additional countries are asking for this information in their native languages. Indonesia, Korea and Australia have recently added labeling requirements for the products registered in their countries. In order to have one international finished good for all of these countries, products now need to have many different specialized labels. Some products just do not have the room to apply all of these labels to the packaging.
These labeling requirements can cause inventory control issues. Many companies must increase the costs of their inventory systems by adding country specific part numbers, or abandon registrations in the countries that are requiring these labels. Medical device companies must have a way to creatively address these requirements in a cost effective manner as this trend of country specific labeling requirements is definitely increasing.