Taiwan’s “Two-Step” Medical Device Review Program Launch Imminent
Questions? Request more information from our specialists
CONTACT USNov 5, 2015
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.
Author
- Stewart Eisenhart
Related
Substantial Medical Device Review Fee Increases at Taiwan Food and Drug Administration
Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.
Major Changes Set for Taiwan’s Medical Device Registration Process
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.