Taiwan Passes New Medical Device Law
Taiwan’s legislature passed the Medical Device Management Law, which separates the country’s regulation of medical devices from pharmaceutical products for the first time.
The bill establishes a standardized registration process for devices as well as fast-track reviews for innovative products. It also sets a lower bar for low-risk devices, allowing for online registration with annual declarations rather than on-site audits.
The new law aims to bring Taiwan in line with international standards as it would establish requirements for quality management systems and tighter controls of the supply chain.