Taiwan’s “Two-Step” Medical Device Review Program Launch Imminent

Taiwanese medical device market regulators are launching their new “two-step” review program on November 10, 2015, after which administrative and technical device reviews will no longer be conducted in parallel.

The Taiwan Food and Drug Administration’s (TFDA) announcement (link in Chinese) of its planned implementation means that from November 10, Taiwan medical device registrants will first need to undergo administrative reviews of their market applications. Once administrative reviews are complete, TFDA reviewers will perform technical reviews of devices under consideration.

As Emergo first reported in April 2015, Under the TFDA’s previous registration framework, administrative and technical reviews could sometimes be conducted concurrently; once the two-step process is in place, Taiwan market applicants may experience lengthier review timeframes.

Emergo’s office in Taipei will continue monitoring TFDA’s implementation and provide additional information as it becomes available.