Digital and AI Innovative Medical Devices, On-site Entry Period Reduced from 390 Days to 80 Days

Integrated Review and Evaluation System for Innovative Medical Devices to be Implemented from the 31st

[Asia Economy Reporter Kim Young-won] The period for digital and artificial intelligence (AI) innovative medical devices to enter the medical field is expected to be shortened to one-fifth.

The Ministry of Health and Welfare and the Ministry of Food and Drug Safety announced that from the 31st, an integrated review and evaluation system for AI and digital innovative medical devices will be implemented. Accordingly, in the future, during the designation process of innovative medical devices, the relevant ministries and related organizations will simultaneously conduct integrated reviews and evaluations.

Previously, the Ministry of Food and Drug Safety designated innovative medical devices, the Health Insurance Review and Assessment Service confirmed the coverage for medical benefits, and the Korea Health Industry Development Institute conducted innovative medical technology evaluations, with reviews conducted separately by each ministry and organization. Because of this, even if designated as innovative medical devices, most were classified as existing technologies, causing long delays in entering the medical field.

Additionally, in the integrated review and evaluation process, the scope of recognition for innovation will be expanded, and the procedures and items for innovative medical technology evaluation will be simplified. The committee review for innovative medical technology evaluation will be reduced from 4-5 times to 2 times, and the existing 14 evaluation criteria will be reduced to 3 items.

The Ministry of Health and Welfare expects that through this system improvement, the number of AI and digital innovative medical devices entering the medical field will increase, and the entry period will be drastically shortened from 390 days to 80 days.

Furthermore, it explained that a significant number of innovative medical devices previously classified as existing technologies and thus not eligible for health insurance benefits will be converted to subjects of innovative medical technology evaluation and will be rapidly used in medical practice.

Applications for the integrated review and evaluation of innovative medical devices can be submitted through the Ministry of Food and Drug Safety’s 'Medical Device Electronic Civil Service Window' from the first Monday to Sunday of every month. For the first implementation of the system, applications can be submitted for one week from the 31st to the 6th of next month.

Meanwhile, besides the integrated review and evaluation of innovative medical devices, the existing general review and evaluation items will also be improved. Until now, when designating innovative medical devices, all evaluation items were uniformly applied to four groups of innovative medical devices with different technical characteristics. In the future, key evaluation items reflecting the characteristics and value of each group will be prepared, and evaluation items will be applied differentially before conducting evaluations.

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