South Korea to Streamline Rules on Medical AI, Digital Technology Devices

The Ministry of Health and Welfare and the Ministry of Food and Drug Safety have recently revealed their plans to amend some related regulations on medical devices.

According to a press release, it is requested to revise the rules surrounding the application and approval of innovative medical devices to allow more AI-powered and digital technology devices to be used immediately in clinical settings.

what is this

The Ministries of Health and Food and Drug seek to incorporate and accelerate the acceptance of devices based on AI/Big Data and digital wearable technologies as innovative medical devices.

Based on Section 2 of the country’s Medical Device Industry Act, innovative medical devices include those medical devices in the fields of ICT, biotechnology and robotics.

An integrated screening and designation system will be established to simultaneously review the designation, certification, and evaluation of innovative medical devices previously performed sequentially.

The system will also combine the process of applying for designation, evaluation, and licensing of innovative medical devices and for medical care benefit or non-benefit evaluation so that these applications can be made within one month. These applications were previously filed with various agencies, including the MFDS, Health Insurance and Review Assessment, and the National Evidence-Based Health Care Support Agency.

Further, the evaluation of innovative medical devices has also been simplified to shorten the approval period by the MFDS, which can take up to 250 days. The consultation process will be reduced to two stages from the previous four to five stages; The discussion committee will also focus on three medical aspects of a device instead of 14.

Why is this important?

Currently, regulatory bodies in South Korea can take more than a year to evaluate and approve an application for designation of an innovative medical device for use in hospitals and other medical fields.

With the proposed changes, it is expected that the period from application to actual use of these innovative medical devices in care settings will now take 80 days. All of these changes will enable AI and digital technologies to be available for use as non-reimbursed or elective benefit tools in the medical field for three to five years.

Both the MOHW and the MFDS will soon develop and disseminate unified guidelines for applications for the designation of an innovative medical device.

A big trend

In August last year, A A global guide to the use of AI in healthcare was released in South Korea. Developed by three organizations, the guide was intended to become a benchmark for the responsible use of AI technologies and to promote clarity and high standards for technology applications in the healthcare sector.

South Korea’s medical device market has seen steady growth over the years. Last year, this rose to 9.1 trillion won ($6.8 billion), growing by 21% on the year. By 2026, the market is expected to reach 12.3 trillion won ($10.9 billion), according to Fitch Solutions.

on record

“We will address the situation where companies run around in sandbags, create better working environments, and proactively eliminate [cumbersome] Regulations in the health and medical field to serve the public and national interest,” said Lee Ki-il, Second Vice Minister of Health and Welfare.

“We hope that the reform of regulations on innovative medical devices will lead to the revival of the high-tech medical device industry using AI and digital technology and the expansion of patients’ medical options,” said Oh Yu-kyung, director of MFDS. commented.

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