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

According to a press statement, there have been requests to review the rules around the application and approval of innovative medical devices to allow more digital and AI-powered devices to be used immediately in clinical settings.


The Ministries of Health and Food and Drugs seek to incorporate and accelerate the adoption of AI/big data-based devices and digital wearable technologies as innovative medical devices.

Based on Article 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 review and designation system will be established to simultaneously review the designation, verification and evaluation of innovative medical devices, which were previously done sequentially.

This system will also combine the application process for the determination, evaluation and licensing of innovative medical devices and for the assessment of the benefit or non-benefit of medical care, so that these applications can be made within one month. These applications have previously been submitted to various agencies, including MFDS, Health Insurance Evaluation and Review, and the National Evidence-Based Health Care Collaborating Agency.

Additionally, the evaluation of innovative medical devices is being simplified to shorten the MFDS approval period, which can take up to 250 days. The discussion process will be minimized to two steps from the previous four to five steps; the discussion committee will also focus on only three medical aspects of a device instead of 14.


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

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 up to 80 days. All these changes will also enable AI and digital technologies to become available for use in the medical field in three to five years as devices with irreversible or selective benefits.

Both the MOHW and the MFDS will soon develop and distribute integrated application guidelines for the designation of an innovative medical device.


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

The medical device market in South Korea has seen steady growth over the past few years. Last year, that rose to 9.1 trillion won ($6.8 billion), up 21% year-on-year. By 2026, the market is forecast to reach 12.3 trillion w ($10.9 billion), according to Fitch Solutions.


“We will solve the situation where companies are running around in sandbags, we will create a good working environment and we will actively eliminate it [cumbersome] regulations in the field of health and medicine to serve the public and the national interest,” said Lee Ki-il, Second Deputy Minister of Health and Welfare.

“We expect that improved regulations for innovative medical devices will lead to the revitalization of the high-tech medical device industry using AI and digital technology and the expansion of patients’ medical options,” Oh Yoo-kyung, director of MFDS, also . commented.

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