Increased Medical Device Registration Fees in Taiwan

The Taiwan Food and Drug Administration (TFDA) has announced regulatory changes and increased fees, effective as of July 1, 2015.

First, TFDA introduced a two-step review program for marketing authorization applicants. The first step of the new process entails review of administrative documents within 10 days of submission. These documents will have to include:

• Application forms
• Quality System Documentation (QSD) approval letters
• Authorization letters
• Certificates to Foreign Governments (CFG) or Certificates of Free Sale (CFS)

This step differs from previous TFDA practice in that registration applications were sometimes accepted without QSD approval letters; the QSD registration process can take five to six months. Taiwanese market applicants now need to obtain QSD approval before submitting their device registration applications.

The second step of the new TFDA process involves review of any necessary preclinical testing documents concerning product safety and performance for Class II and III devices, as well as facility quality control documentation.

In addition to the new review process, TFDA has also increased registration fees significantly. 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.

Sources: http://bit.ly/1GdGMeK // http://bit.ly/1NOzjFp // http://bit.ly/1fGSzcN