There are a few methods manufacturers can use to properly label their products and successfully gain market clearances worldwide. These different methods require consideration of the time, cost, and risk involved for your company. Common to all of them is the requirement for translation of the labeling. For all major markets, and many emerging markets, the product labeling is required to be in the country’s official language. Depending on your approach, your market clearance registration dictates where the responsibility for translation lies. Review and control of the finished label, and the risks involved if the translation is incorrect, are considerations that every manufacturer must factor into their market clearance planning.
For the methods described in this report there are certain import/export requirements that must be considered. Manufacturers based in the United States must either register the product internationally using the same product code used for their domestic registration, or they must register the product under a different product code for the Rest of the World (ROW). Methods similar to the ones described below are applicable for many non-US manufacturers as well.
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