Lawmaker pushes to expand innovative medical devices to those that improve convenience in diagnosis and treatment

A bill has been proposed to expand the scope of medical devices eligible for designation as “innovative medical devices” to include those that improve the convenience of diagnosis and treatment.

Rep. Lee Joo-young of the splinter opposition New Reform Party, a member of the National Assembly's Health and Welfare Committee, introduced the bill on Tuesday, titled the “Amendment to the Medical Device Industry Promotion and Innovative Medical Device Support Act.”

The amendment allows medical devices that improve the convenience of diagnosis and treatment, in addition to safety and efficacy, to be designated as innovative medical devices.

Companies researching and developing innovative medical devices can receive benefits, including priority participation in national research and development projects, tax breaks, and reduced fees. However, the current criteria for designating innovative medical devices are limited to improvements in safety or efficacy, resulting in cases where devices that significantly improve usability are not designated as innovative medical devices.

“Medical devices that improve the convenience of diagnosis and treatment, in addition to safety and efficacy, can enhance patients’ access to treatment and improve the efficiency of medical staff’s diagnosis and treatment, thereby bringing benefits to the overall healthcare system,” Rep. Lee said. “Therefore, there is a strong need to designate such devices as innovative medical devices and support their research and development.”

If the amendment is passed, it will promote more research and development of medical devices, enhancing the overall benefits of the healthcare system, Lee added.