Korea’s Ministry of Food and Drug Safety is now accepting real-world evidence (RWE) as clinical data for medical device approval decision-making. This opens up a pathway for medical device manufacturers to accelerate development with real-world data (RWD) resources like clinical data from devices, electronic health records (EHR), and claims data.
According to Kim Chan-hyuk, “The ministry explained that recognizing RWE as clinical trial data complements the 2019 guideline for applying RWE for medical devices, previously operated as a yardstick to secure predictability and reliability in medical device approval reviews. The regulator noted that the RWE data could be applied to new approvals or changes in the purpose of use of the above medical devices. However, it added that prior consultation or discussion may be required for the approval process using RWE data.”
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(Source: Korean Biomedical Review, June 6th, 2023)