Labeling: The Path to Global Market Clearance

Labeling Impact on Worldwide Market Clearance

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 below 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.

The following has been summarized and outlined in Labeling: The Path to Global Market Clearance-

• Methods commonly used for market clearance
• Commonly encountered labeling related issues
• Recommendations and helpful hints
• The industry's best practices

Excel Translations specializes in medical device labeling translation, diagnostic products labeling translation, pharmaceutical labeling translation, and life science labeling translation. Common labeling translation services include the translation of user’s guides, the translation of IFU, the translation of medical inserts, and the translation of user interface scripts. Contact us for more information about our medical translation services.