Medical device registration in Taiwan
Taiwan is a growing economy and the demand for medical devices is growing exponentially there. The health agency of Taiwan is called as Taiwan Food & Drug Administration (TFDA) . The agency classifies the devices into 3 classes based on risk.
The Taiwanese regulatory system classifies devices as Class I, II or III depending on risk. Class II and III devices must have home country approval in place prior to Taiwanese registration.
With a presence in Taipei, we can assist with all aspects of the TFDA registration process, including application preparation and submission and in-country representation.
How to register for your medical devicein Taiwan For Class I - Submit application to TFDA
For Class II & III- Submit Dossier , this is similar to your CE technical file contents.
Comply with Quality System Documentation (QSD) certification
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
