Division Introduction

The Standardization Division is responsible for projects to standardize laboratory operations and for performance evaluation of in vitro diagnostic medical devices commissioned by the Ministry of Food and Drug Safety, with the goal of ensuring the reliability of diagnostic testing through laboratory operation standardization and in vitro diagnostic medical device performance evaluation. Along with standardization activities to improve the accuracy and reliability of testing, the division objectively evaluates the performance of marketed in vitro diagnostic medical devices and contributes to protecting public health.

Standardization of Laboratory Operations

• Development of performance evaluation guidelines for reagents and instruments: to ensure consistency and reliability in performance evaluation, the division develops performance evaluation test methods and decision criteria for reagents and instruments.
• Systematization of evaluation items and performance evaluation methods.
• Ensuring consistency and reliability of performance evaluation.
• Application and dissemination of standardized evaluation processes.
• Development of standard reports for interpreted test results: to improve the reliability of reports through standardization of reporting for test results requiring specialist interpretation, the division defines report structure and required elements.
• Definition of report structure and required elements.
• Promotion of improved reliability of test results.
• Promotion of field dissemination of standardized report forms.

In Vitro Diagnostic Medical Device Performance Evaluation Project

The division conducts post-market performance evaluation projects for approved in vitro diagnostic medical devices and evaluates whether the quality of marketed in vitro diagnostic medical devices is maintained consistently.

• Establishment of an in vitro diagnostic medical device performance evaluation system.
• Implementation of in vitro diagnostic medical device performance evaluation.
• Development of quality management and monitoring strategies.