ARTICLE SUMMARY:
South Korean regulators have released multiple policies impacting medtech products, including a new fast-track market pathway. Excerpted from Pathways’ Picks January 28: South Korea Fast Track, Minnesota Letter, PPE Supply Ideas, and More.
Innovative new devices that undergo enhanced clinical evaluation in South Korea can skip a time-intensive “new medical technology assessment” step and get to market more than a year earlier than usual under a new accelerated market entry pathway announced January 26 [link in Korean]. Typically, devices that are new to the South Korean market must undergo extra assessments that can last up to a year or more. But qualifying new devices that pass initial regulatory review based on enhanced, “internationally recognized” clinical evaluation standards can bypass these additional reviews. The Ministry of Food and Drug Safety (MFDS) says 199 devices, including digital health devices, in vitro diagnostics and medical robots, are currently eligible for the fast-track pathway. The government reserves the right to perform extra assessments while the technology is on the market.