The South Korean government reached an agreement with the nation’s medical device industry to adopt accelerated approval procedures for certain devices.
The Korean Fourth Industrial Revolution Committee — a state committee chaired by Korean President Moon Jae-in — led a marathon policy discussion to determine strategies for regulating devices. Participants in the discussion included government agencies such as the Ministry of Drug and Food Safety and the Ministry of Health and Welfare, along with medical technology companies based in the country.
One of the group’s key concerns was devices whose success depends on entering the market before the competition. Under the consensus reached, the government will establish a fast-track approval path for next-generation devices for which a first-entrant advantage is vital.
The committee also will create a value-based evaluation pathway that factors potential clinical and societal benefits into the approval process along with clinical evidence. Devices approved based on this assessment will be granted a clinical usage period of three to five years followed by a re-evaluation, according to the committee.
South Korea’s Ministry of Food and Drug Safety has joined the International Medical Device Regulatory Forum. The ministry has determined the forum’s Medical Device Single Audit Program, a common set of audit requirements for all member nations, could be applied in Korea. — Zack Budryk