ARTICLE SUMMARY:
In this week’s Pathways Picks: South Korea regulators unveil an accelerated pathway for innovative devices as part of an active week of medtech efforts; device execs sign on to letter seeking de-escalation in Minnesota; CMS seeks input on plans to increase purchasing of domestic PPE supplies; CDRH posts annual report; and medtech policy updates from FDA, Europe, China, and Malaysia.
South Korea Fast Track
Regulators met with device executives in Seoul last week amid the release of multiple policies impacting medtech products, including a new fast-track market pathway (all links in Korean):
Speeding innovative device approvals. 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. 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.
