Taiwan Passes New Medical Device Management Law

Taiwan’s legislature passed the Medical Device Management Law, which separates the 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 approvals for innovative products.

The new bill seeks to bring Taiwan in line with international quality management requirements. It also sets a lower bar for low-risk devices, allowing for online registration with annual declarations rather than on-site audits.