Medical device registration in Taiwan
Taiwan has a growing demand for Medical Devices. The Taiwan Food & Drug Administration (TFDA) under Ministry of Health and Welfare (MOHW) regulates Medical Devices through Pharmaceutical Affairs Act (PAA). The agency classifies the devices into 3 classes based on risk. Class-I for low-risk, Class II for moderate-risk and Class III for high-risk devices. The need for a predicate device to market poses challenge for novel devices to enter the market. Increased procedural time gap for Class II and III devices needing Quality System Documentation is another complexity involved.
How to register for your medical devicein Taiwan
Process flow
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
