The client is a Japan based leading global conglomerate providing high-value-added products and services in the areas of oral care, health, and beauty. The company recently developed a unique product for oral care and was looking for assistance in classification and registration of the new technology under medical devices. Some of the challenges Freyr faced was interaction with Agency in Taiwan and translation of all the documentation into Chinese.
This case explains how Freyr achieved the results in spite of some critical languages and successfully classified and registered the device with the TFDA.