Pre-market approval is necessary for all classes of medical devices prior to Taiwanese market entry.
Foreign manufacturers must demonstrate their compliance with Good Manufacturing Practice (GMP) requirements by submitting Quality System Documentation (QSD) prior to registration for many devices.
The Taiwanese regulatory system classifies devices as Class I, II or III depending on risk. This system is based on the US FDA medical device classification scheme. Class II and III devices must have home country approval in place prior to Taiwanese registration.
Class I sterile, Class I measuring, Class II and Class III medical devices must comply with GMP requirements before product licenses are granted by the TFDA. TFDA Authorized Auditing Organizations perform on-site inspection for local manufacturers in accordance with GMP and also review Quality System Documentation (QSD) provided by foreign manufacturers.