Annual Approval of Advanced Medical Devices Including AI Medical Devices Increases by 20%

[Asia Economy Reporter Cho Hyun-ui] The approval of advanced medical devices that combine bio and IT technologies, such as artificial intelligence (AI)-based medical devices, has steadily increased by nearly 20% annually over the past three years.

The Ministry of Food and Drug Safety (MFDS) announced this on the 29th when publishing the "2019 Medical Device Approval Report."

According to the report, a total of 8,269 medical devices were approved, certified, or registered last year, marking a 6.8% increase compared to the previous year. The MFDS explained, "There has been an increase in AI-based medical devices, an expansion in the domestic manufacturing ratio of high-risk Class 4 medical devices, and a rise in the development of silver medical devices for the elderly."

Last year, a total of 10 AI-based medical devices were approved. This number has been increasing annually from zero in 2017, to four in 2018, and ten in 2019. All approved products last year were domestically developed software medical devices that analyze medical images such as endoscopy and X-rays to assist in diagnosis or detection. Additionally, the approval of advanced medical devices combining bio and IT technologies has steadily increased by an average of 19.3% annually over the past three years.

The status of imported medical device approvals last year was 4,664 cases (56.4%), which increased compared to the previous year (4,145 cases, 53.5%), raising their proportion. This is explained by the high import dependence of low-risk Class 1 and 2 devices, such as blood pressure monitors and contact lenses, which make up the majority of medical devices.

On the other hand, the domestic manufacturing ratio of high-risk, high value-added Class 4 medical devices has gradually increased. The manufacturing ratio for Class 4 devices last year was 77.6% (267 cases), higher than the previous year’s 76.7% (198 cases).

With the advent of an aging society, silver medical devices such as glasses, hearing aids, and implants that assist the healthy daily activities of the elderly have generally increased across all classes. Furthermore, the development of 'combination medical devices' and 'single-set medical devices,' which package multiple products together for easier use by users, has become more active, resulting in an increase in the number of approvals compared to the previous year.

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