Snapshot

The Expedited Review Pathway for Medical Devices (including IVDs) pathway has been developed by the of South Korea.

This pathway can be used where Classifies IVDs as medical devices and offers three market authorization pathways depending on device class (risk). Device Classes: Four risk classes based on potential patient harm: - Class I: Low risk (e.g., bandages, surgical instruments) - Class II: Low to medium risk (e.g., thermometers, infusion pumps) - Class III: Medium to high risk (e.g., orthopedic implants) - Class IV: High risk (e.g., pacemakers, heart valves) Market Authorization Pathways: - Class I: Registration by notification, no technical review or KGMP required. - Class II: Certification route if substantially equivalent device exists (faster pathway); otherwise, pre-market approval with technical file review and KGMP certification. - Class III & IV: Pre-market approval with extensive technical and clinical documentation review, KGMP mandatory. Expedited registration available especially for devices recognized as novel or with substantial equivalency. Review process includes K-GMP certification and local clinical/testing requirements. Clinical data submission required for devices with no predicate, supporting safety and performance. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is .