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
South Korea – Partial Amendment to the «Regulations on Medical Device Manufacturing and Quality Management»
