New Medical Devices Act Goes Into Effect in Taiwan With New Safety Measures, Fees

Taiwan’s long-anticipated new law regulating medical devices modifies the way devices are classified, mandating they be grouped by product category and risk, adjusts device registration fees, and mandates adherence to certain technical guidelines for preparing documents related to device registration applications. The Medical Devices Act went into effect on May 1.

The new law establishes new procedures for registrations, renewals, and post-approval modifications of medical devices. It ramps up the surveillance of the safety of devices after they are approved and are on the market in Taiwan, and establishes regulations governing device recalls. It also increases the instances for which samples of devices, particularly in vitro devices, will be required during the registration process.