South Korea - Proposed Amendments to the Medical Device Act Enforcement Regulations
Business description
The Ministry of Food and Drug Safety (MFDS) issued Public Notice No. 2026-110 on March 3, 2026, proposing changes to streamline medical device management and improve safety protocols.
Key updates include shifting to a self-managed system for non-critical changes to device approvals, shortening the processing time for conditional approval inspections from 20 to 10 days, and clarifying legal grounds for recalling products that fail specific test specifications.
The public is invited to submit opinions on these measures, which aim to reduce administrative burdens and enhance response times in the medical field, until the designated deadline.
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