• 12/07/2026 23:55

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  • South Korea – Proposed enactment of the “Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices”

South Korea – Proposed enactment of the “Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices”

South Korea - Proposed enactment of the “Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices”

South Korea – Notice of Partial Amendment to the Standards for Medical Device Manufacturing and Quality Management

South Korea - Notice of Partial Amendment to the Standards for Medical Device Manufacturing and Quality Management

South Korea – Draft Amendment to the Operational Guidelines for Safety Management of Electrical Appliances and Consumer Products

South Korea - Draft Amendment to the Operational Guidelines for Safety Management of Electrical Appliances and Consumer Products

South Korea – Proposed Amendments to the Regulation on the Permission, Notification, Review, etc. of Medical Devices

South Korea - Proposed Amendments to the Regulation on the Permission, Notification, Review, etc. of Medical Devices

South Korea – Proposed Amendments to the «Enforcement Rule of the Medical Devices Act»

South Korea - Proposed Amendments to the "Enforcement Rule of the Medical Devices Act"

South Korea – Proposition of Amendments to the “Regulation on In Vitro Diagnostic Medical Device Group and Class by Group”

South Korea - Proposition of Amendments to the “Regulation on In Vitro Diagnostic Medical Device Group and Class by Group”