Simplification of Digital Therapeutic Device Reexamination... Regulatory Innovation Across Food and Medical New Industries

Director Oh Yu-kyung Visits LifeSemantics to Hear Field Opinions

[Asia Economy Reporter Jo In-kyung] Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, promised to actively discover and promote regulatory innovation policies across new industries, including digital healthcare and new industrial medical device sectors, as well as food and pharmaceutical fields.

On the afternoon of the 17th, Commissioner Oh visited LifeSemantics, a digital healthcare device manufacturer located in Gangnam-gu, Seoul, to inspect the development site and listen to opinions from the field, and made these remarks.

LifeSemantics is a digital healthcare device manufacturer that develops software medical devices, such as devices linked with software applications (apps) that assist in the rehabilitation of patients with respiratory diseases or cancer.

Commissioner Oh emphasized, "Through proactive regulatory innovation based on scientific knowledge and expertise, we will solve various problems faced by companies and spare no policy support to ensure that the domestic medical device industry is recognized in the global market."

Song Seung-jae, CEO of LifeSemantics, said, "We are currently developing digital therapeutics that assist respiratory rehabilitation and plan to expand the target to cardiac diseases and cancer patient rehabilitation in the future," adding, "We ask the Ministry of Food and Drug Safety to create related guidelines so that these products can be developed quickly."

CEO Song also requested, "Based on user feedback of digital therapeutics, the software upgrade process to improve usability and convenience must be repeated several times," and "Considering that software distribution is impossible during the change review period, please simplify the change review procedure."

In response, Commissioner Oh said, "We plan to continuously publish clinical trial evaluation guidelines by disease to ensure that products under development can be quickly marketed," and added, "Only important matters such as the core performance of medical device software will undergo change approval procedures, and matters not applicable will be revised to allow companies to update autonomously."

The Ministry of Food and Drug Safety plans to support regulatory innovation that redesigns regulations for digital healthcare devices based on data and communication, from clinical trials to post-market, so that it can drive not only safety management but also the growth of new industries.

This content was produced with the assistance of AI translation services.