publicMinistry of Food and Drug Safety (MFDS) · South Korea · Updated Aug 13, 2026
Partial Revision of the Regulations on the Management of Safety Information for Medical Devices
Manufacturers and stakeholders in South Korea must review and update their safety reporting systems and Standard Operating Procedures (SOPs) to comply with the revised regulations.
ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Consultation / Administrative Notice
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