South Korea’s government and businesses have agreed to newly adopt “fast-track” approval procedures for next-generation medical devices whose success hinges on entering the market ahead of competitors.
They also agreed to push for new policies that would allow innovative medical devices to be certified on a global basis, as well as adopt a new “value-based” evaluation system for novel medical technologies with immediate value to society.
The consensus was forged during an inaugural marathon policy “hackathon” discussion led by Korea’s Fourth Industrial Revolution Committee chaired by President Moon Jae-in, the results of which were announced on Dec. 27.
The discussion on revising regulations for next-generation medical devices was carried out by related government bodies including the Ministry of Health and Welfare and the Ministry of Drug and Food Safety as well as Korea’s flagship medical technology startups like Healcerion, Ybrain and Lunit.
Like other countries, Korea has been working to draw up effective regulations governing new medical technologies and devices being built in Korea, to help their safe and quick launch in Korea as well as other global markets.
For new cutting-edge medical devices -- often novel technologies that have paved a new product category of their own -- it’s crucial that are launched on the market before others to gain a first-entrant advantage.
Considering this, the President Moon-led state committee has agreed to deploy specialized fast-track approval procedures for products considered as “next-generation medical devices.”
It will also create a “value-based evaluation track” within its new medical technology evaluation policy that approves a product based on not only hard evidence but the device’s societal and clinical benefits.
The medical technologies that pass the “value-based evaluation” will undergo three to five years of clinical usage period, after which it will undergo a re-evaluation, the state committee said.
In addition, the committee agreed on the need to allow higher health insurance reimbursement rates for innovative medical devices to reflect their value. It also pledged to step up efforts to convince the legislature to pass the new medical growth law.
The policy consensus forged during the recent discussion will be reflected in the ongoing lawmaking procedures at the ministries as well as the National Assembly, the committee said. The related progress and outcomes will be announced at the second “hackathon” session in June.
By Sohn Ji-young/The Korea Herald (email@example.com