In the future, if sufficient real-world evidence (RWE) is secured to obtain approval for medical devices incorporating digital technology, separate clinical trials may no longer be necessary. Since this had been one of the obstacles in the development of digital therapeutics (DTx) and artificial intelligence (AI) medical devices, this change is expected to enable more active development.
The Ministry of Food and Drug Safety (MFDS) announced on the 1st that it has revised the "Regulations on Approval, Notification, and Review of Medical Devices" (MFDS Notice) to include these provisions.
Previously, clinical trial data involving human subjects or data from papers and literature had to be submitted as clinical trial evidence for approval. However, going forward, clinical evidence derived from processing and analyzing various routinely collected healthcare-related data?such as patient health status generated using medical devices, electronic medical records (EMR), and medical information from the National Health Insurance Service?can be utilized as clinical data for approval. The medical devices to which this new system applies include ▲ medical devices incorporating digital technologies such as big data and AI ▲ designated medical devices requiring rare or urgent introduction ▲ medical devices manufactured using 3D printers.
The MFDS also defined the RWE data and stipulated the necessary items to ensure the quality and reliability of the data. To qualify as RWE that can replace clinical data, the following must be included: ▲ validity of the type, source, collection method, selection criteria, and exclusion criteria of real-world information ▲ information on the medical device used ▲ plans, execution, and result analysis necessary for collecting and evaluating real-world information ▲ personnel involved in collecting and analyzing usage information ▲ indications, performance, procedure methods, and analysis items of the real-world information.
This revision was made to supplement the previously operated "Guidelines on the Application of RWE for Medical Devices" by incorporating it into approval regulations to secure predictability and reliability in medical device approval reviews. RWE data can be applied to new approvals or changes in the intended use of the target medical device. However, the MFDS added, "Prior consultation or discussion may be necessary when proceeding with approval using RWE data."
Kang Sung-ji, CEO of Welt, a DTx developer and head of the DTx subcommittee of the Korea Medical Devices Industry Association’s Innovation Industry Committee, evaluated, “By actively utilizing RWE for safety and efficacy verification, it will be possible to establish flexible development strategies suited to the characteristics of software as a medical device (SaMD).”
The MFDS also stated, "This revision will promote the development of digital medical devices using big data information collected from actual medical environments," and added, "It is expected to help medical device manufacturers and importers quickly launch safe and effective medical devices into the market."
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