The Taiwan Food and Drug Administration (TFDA) has announced a registration fee increase that will be effective as of July 1, 2015.
Registration fees for Class I devices will decrease slightly, while fees for Class II and III devices will increase by several hundred dollars each. A Class II medical device will now cost almost $1,000 to register, and a Class III device will cost approximately $1,400. Fees for novel devices will be even higher.
In addition, the fees have also been increased to obtain a medical device import authorization, renew a product license, and modify existing device registrations and licenses – such as changing the product indications or the manufacturing site.