The Ministry of Food and Drug Safety announced on the 20th that it has prepared and released three English guidelines for digital health medical devices, including artificial intelligence (AI) and digital therapeutics (DTx), to support the overseas expansion of digital health medical device companies.
Cover of the 'Digital Therapeutic Device (DTx) Approval Review Guidelines' recently published in English by the Ministry of Food and Drug Safety [Image source=Ministry of Food and Drug Safety]
The newly prepared guidelines include ▲ Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices (for public) ▲ Guidance on Clinical Trials Design of Artificial Intelligence (AI)-based Medical Devices (for public) ▲ Guidance on the Review and Approval of Digital Therapeutics (DTx) (for public). These were developed as part of the national project for ‘Innovation in Regulatory Science for Bio and Digital Health Product Commercialization,’ with consultations from experts of the Korean Society of Digital Therapeutics, the Korean Society of Medical Artificial Intelligence, and clinical specialists to enhance completeness.
The Ministry plans to share the newly prepared English guidelines with member countries of international medical device organizations such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP), and actively utilize them for international regulatory harmonization to make Korean regulations global standards. Previously, the DTx guideline published in 2020 was cited last month in the International Organization for Standardization (ISO) technical report, serving as a reference for DTx developers worldwide, demonstrating the growing international influence of Korea’s standards.
An official from the Ministry of Food and Drug Safety stated, "We will proactively establish a legal framework for digital medical products in line with the digital transformation era and continuously advance a rational regulatory system for digital new technologies." He added, "Furthermore, we will actively promote the excellence and rationality of our regulations worldwide to support the smooth export of domestically produced digital health medical devices."
Detailed information about the guidelines can be found on the Ministry of Food and Drug Safety’s official English website.
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