After two years of delays, Taiwan’s legislature in January passed legislation establishing dedicated regulations on medical devices. The Medical Device Management Law, which has not yet been signed by Taiwan’s president, separates the regulation of medical devices from pharmaceutical products in the country for the first time. The legislation establishes a standardized registration process for devices, as well as fast-track approvals for innovative products. It seeks to bring Taiwan in line with international quality management standards and create a mechanism to obtain quick approvals for innovative products. It also sets a lower bar for limited-risk devices, allowing registration online and dispensing with on-site audits in most cases.
