New bills aimed at promoting the use of medical devices have been introduced in Korea’s National Assembly. The government is aiming to boost the devices industry as it pursues broader reforms to expand national healthcare coverage to include all previously non-reimbursed services and products. One bill proposes a new risk-based approach to regulating the production, import, sale, and use of in-vitro diagnostics. The aim of the bill is to better harmonize the regulation of in-vitro diagnostics with that of other countries. Another bill aims to define “high-tech medical devices” for different uses and grant manufacturers and importers the right to a step-by-step evaluation.
President Moon Jae-in’s pledge to expand healthcare coverage to cover 70 percent of people’s costs is expected to increase demand for medical devices and services. The 30.6 trillion won ($28 billion) plan—dubbed “Moon Care”—will be implemented in stages through 2022. The Korea Medical Devices Industry Association has organized a task force team to contribute to the policymaking process, particularly with regard to resolving issues around non-reimbursed medical devices.