The Ministry of Food and Drug Safety of South Korea plans to amend the «Enforcement Rule of the In Vitro Diagnostic Medical Devices Act» to introduce the following key changes: – Performance Evaluation Standards: The performance evaluations for in vitro diagnostic medical devices will be conducted according to the standards and specifications from the Medical Devices Act or specific criteria and methods established by the Minister of Food and Drug Safety. – Submission Requirements: Individuals or organizations seeking performance evaluations must submit technical documents, test specimens, reference materials, and other necessary materials to a designated institution authorized by the Minister of Food and Drug Safety. – Delegation of Evaluation: The responsibility for performance evaluations can be delegated to institutions or organizations with recognized expertise in testing or diagnosing in vitro diagnostic medical devices. These amendments aim to ensure thorough and standardized evaluation processes for such medical devices.
South Korea – Proposed Amendments to the «Enforcement Rules of the In Vitro Diagnostic Medical Devices Act”
