Taiwan Increases Medical Device Registration Fees

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.

Despite these small increases, the government fees for device registration in Taiwan are just a fraction of the government fees for China.