Report: Korea to adopt ‘fast-track’ approval for next-gen med devices

South Korea’s regulatory bodies have agreed to adopt a “fast-track” approval process for next-generation medical devices, according to a new report from the Korea Herald.

The policies are being enacted to promote medical devices whose success is dependent upon entering the market ahead of their competitors, and would allow devices to be certified on a global basis, according to the report.

A new value-based evaluation system will be developed for such devices, aiming to explore their immediate value to society, the Korea Herald reports.

The discussion over next-generation medical device regulations was performed by a group of government bodies including the Ministry of Health and Welfare and the Ministry of Drug and Food Safety and was joined by flagship medtech startups Healcerion, Ybrain and Lunit, according to the report.

The “value-based evaluation track” will reportedly not only explore scientific evidence on the device but also consider the technology’s “societal and clinical benefits,” according to the Korea Herald.

The group also agreed on upping health insurance reimbursement rates for innovative medical devices, according to the report.

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