Tag archive

Ministry of Food and Drug Safety (MFDS)

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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publicMinistry of Food and Drug Safety (MFDS) · South Korea · Updated Jul 31, 2026

New Drug Product Licensing and Review Work Procedures (Civil Servant Guidelines)

Urgency: High

Marketing authorization holders (MAHs) must align their RMP submissions with the updated MFDS checklists to comply with the new review procedures.

Country ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guideline / SOP

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