MFDS sets out two clinical accuracy evaluation routes
South Korea’s Ministry of Food and Drug Safety (MFDS) issued the Guideline for Evaluating the Clinical Accuracy of Non-Invasive Automated Blood Pressure Monitors on August 31, 2026. The guide follows changes to the clinical accuracy requirements for automated electronic sphygmomanometers under Korea’s medical device standards and is intended to clarify the methods and criteria used to evaluate clinical accuracy.
MFDS describes two reference approaches for clinical accuracy evaluation. A study may compare the device under evaluation with auscultatory blood pressure measurements or with invasive arterial blood pressure measurements, depending on the applicable product and study design.
For the auscultatory reference route, the guide addresses requirements including subject numbers, sex, age, cuff-related factors and blood pressure distribution, together with study and analysis methods. It also provides corresponding requirements, study methods and analysis methods for the invasive reference route.
The guide additionally addresses clinical investigations involving pregnant participants, including people with pre-eclampsia. MFDS states that the clinical investigation design and test criteria are aligned with the internationally used ISO 81060-2 framework.
What manufacturers should review first
Companies with Korean submissions involving automated electronic sphygmomanometers should first confirm which reference method their clinical evidence uses and whether the study population, cuff configuration, blood pressure distribution, test method and analysis method remain aligned with the new MFDS guidance.
For multiparameter patient monitors, the practical question is whether the non-invasive blood pressure function and its Korean technical documentation rely on the same automated sphygmomanometer clinical accuracy requirements. If so, the NIBP validation strategy and supporting clinical evidence should be reviewed against the new guide.
Products described broadly as wrist-worn, wearable or cuffless blood pressure devices should not automatically be assumed to fall within this guide solely from their form factor. Applicability should be confirmed against the Korean device classification, measurement principle and submission pathway for the specific product.
The guide is an implementation reference for the revised clinical accuracy requirements. Manufacturers should continue to assess the binding Korean medical device standards and product-specific approval requirements that apply to their submissions.
Sources
- Primary official source비침습 자동혈압계의 임상 정확도 평가 가이드라인 (opens in a new tab)Ministry of Food and Drug Safety
- Supporting source[보도참고] 식약처, 비침습 자동혈압계 임상정확도 평가 가이드라인 제정 (opens in a new tab)Ministry of Food and Drug Safety