The Ministry of Food and Drug Safety has decided to recognize real-world evidence (RWE) as clinical data in the approval process for digital technology-based medical devices.
The ministry said Thursday that it has revised the “Regulation on approving, reporting, and screening medical equipment” to recognize RWE as clinical trial data for approving medical devices that utilize digital technologies such as big data and artificial intelligence (AI).
RWE in medical devices, as defined by the ministry, is clinical evidence on the results of using medical devices, potential benefits, and risks derived by processing and analyzing medical-related data routinely collected from various sources, such as patient health status generated by using medical devices, electronic medical records, and medical information of the National Health Insurance Service (NHIS).
Thanks to this revision, RWE data will be recognized as clinical trial data to confirm safety and efficacy when approving medical devices with digital technologies, such as big data and AI, medical devices designated as rare or urgently needed for introduction, and medical devices made using 3D printers. Currently, applicants must submit human test data or papers and literature.
Besides, the food and drug safety ministry stipulated the definition of RWE data and matters that should be included to ensure reliability, such as the data quality.
Among them are:
● The validity of the type, source, collection method, selection criteria, and exclusion criteria of the RWE.
● Information on the medical devices used.
● Information on the planning, implementation, and result analysis required to collect and evaluate the RWE.
● Personnel involved in the collection and analysis of the information used.
● Indications, performance, procedure methods, and analysis items of the RWE.
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.
“By actively utilizing RWE for safety and validation, it will be possible to establish a flexible development strategy tailored to the characteristics of software medical devices,” Welt CEO Kang Seong-ji said. Kang, who has led Welt, a digital therapeutic device developer, doubles as head of the DTx Division of the Innovation Industry Committee of the Korea Medical Devices Industry Association (KMDIA).
The ministry said, “We expect this revision to promote the development of digital medical devices utilizing big data information from real-world medical environments and help medical device manufacturers and importers to bring safe and effective medical devices to market quickly.”
Source: https://www.koreabiomed.com/news/articleView.html?idxno=21257