Apr 16, 2015

The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.

The regulatory changes will take effect starting July 1, 2015.

First, TFDA will introduce a two-step review program for marketing authorization applicants. The first step of the new process will entail 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 will differ from current TFDA practice in that registration applications are now sometimes accepted without QSD approval letters; the QSD registration process can take five to six months. So once the TFDA system is implemented, Taiwanese market applicants will need to obtain QSD approval before submitting their device registration applications.

The second step of the new TFDA process will involve 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 is also planning a significant registration fee increase. Exact figures will be included in the regulator’s official notification, expected to be published in the near future.

Emergo will provide further details once TFDA issues official notification of these changes.


  • Stewart Eisenhart