The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) has approved clinical trial data for medical devices applied with digital technologies such as big data and artificial intelligence (AI), etc. On the 1st, it was announced that the ‘Regulations on Medical Device Approval, Notification, Review, etc’ were amended.
RWE relates to the results of the use of medical devices or potential benefits arising from the processing and analysis of medical-related data collected on a daily basis from various data such as the patient’s health condition, electronic medical records, and medical information from the National Health Insurance Corporation . produced by the use of medical devices It refers to clinical evidence of risk.
Joo Seon-tae, head of the Medical Devices Policy Division of the Ministry of Food and Drug Safety, said in a press release on the 1st, “With this review, medical devices have been applied with digital technology such as big data and AI, △ medical devices designated as rare and in urgent need of introduction, and △ manufactured using 3D printers. For approved medical devices, RWE data are recognized as clinical trial data to confirm safety and efficacy.Previously, the Food and Drug Safety Administration only accepted human trial data or literature papers and data.
In addition, through this review, the Ministry of Food and Drug Safety identified issues to be included to ensure reliability, such as RWE data definition and data quality. The main content is △ validity of type, source, collection method, selection criteria, and exclusion criteria actual use information △ information about medical devices used △ issues related to planning, implementation, and analysis of results needed to collect and evaluation of actual use information △ use Personnel who participated in information collection and analysis △ Indications, performance, treatment methods, and actual use information analysis items.
Seon-tae Joo, the manager, said, “The accreditation of clinical trial data for RWE data complements the ‘guidelines for the application of evidence from actual use of medical devices’ to date, and to ensure the predictability and reliability of medical device approval. review by including it in the approval regulations.” “RWE data can be applied to new approvals or changes to the purpose of use of the medical devices mentioned above, and it may be necessary to consult or negotiate in advance when proceeding with approving their use,” he explained.
Director Joo continued, “The Ministry of Food and Drug Safety said that this review promotes the development of digital medical devices using big data information used in the actual medical environment, and helps medical device manufacturers and importers launch safe and effective quickly on the I hope this will be the case,” he added.
Seongji Kang, CEO of Welt, a digital manipulation device developer (Director of DTx, Innovation Industry Committee, Korea Medical Device Industry Association), said, “By actively using RWE for checking safety and effectiveness, it will be possible to establish flexible development. a strategy that matches the characteristics of software medical devices.” it was said
