MDREX Newsletter

2024.4.26.

MFDS Approves DTx  No. 3 and 4 in Korea

Following the approval and temporary insurance coverage of digital therapeutic devices (DTx) for treatment of insomnia, two additional digital therapeutic devices have received product approval from the Ministry of Food and Drug Safety (MFDS) as of April 19, 2024.

1. Nunaps : VIVID Brain

• VIVID Brain is designed to improve narrowed vision in patients with brain disorders by providing 12 weeks of repetitive visual perceptual training. This product offers striped pattern comparison or moving visual perceptual learning via VR, personalized cognitive training relative to visual stimulation location, and age-adjusted training based on the training results over 12 weeks.

2. Share & Service: EasyBreath

• EasyBreath aims to provide 8 weeks of personalized respiratory rehabilitation training for patients with chronic obstructive pulmonary disease, asthma, lung cancer, etc. This program focuses on aerobic exercise-based rehabilitation, such as walking based on a 6-minute walk test, to improve aerobic exercise capacity and relieve respiratory symptoms. Patients tend to install the product on their smartphones and utilize a mobile app for personalized pre-rehabilitation assessment, tailored exercise prescription, respiratory rehabilitation exercises, track record, and respiratory rehabilitation outcome over 8 weeks.

Additionally, if these products are designated as innovative medical technologies, hospitals will receive reimbursement for a period of 3 years; 1) a digital therapeutic device prescription fee of 5,230 KRW, 2) a digital therapeutic device effectiveness evaluation fee of 16,130 KRW and, 3) the usage fee will be reimbursed based on the cost set by the company multiplied by the prescription days. Therefore, companies planning to develop or introduce digital therapeutic devices in Korea should closely monitor the regulatory compliance regarding the products as mentioned above.

At MDREX, we offer precise, unparalleled support for approval and insurance registration with regard to various medical devices such as digital therapeutic devices entering into Korea, Japan, APAC, and Middle East. If you require consultation on product approval and insurance inclusion, please feel free to contact MDREX at pro@mdrex.co.kr.

Thank you