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South Korea - Partial Amendment to the "Regulations on Medical Device Manufacturing and Quality Management"
The objective of this amendment is to enhance the efficiency and rationality of the medical device conformity assessment system to:
- Ensure rapid supply of critical medical devices used for life support, surgeries, and emergencies.
- Reduce repetitive conformity assessments for manufacturers with valid certifications for the same product group.
- Clarify the scope of on-site inspections to ensure consistent assessments.
- Standardize the validity period of certificates during combined audits to align with international standards.
Key Changes:
- Priority Review for Critical and Innovative Medical Devices
- Simplification of Conformity Assessment for Outsourced Manufacturing
- Clear Definition of On-Site Inspection Scope
- Defining Validity Period for Combined Certification Audits
Source Link:
Notice No. 2025-439