March 29, 2023

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

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


The Health and Food and Drug Ministries seek to include and expedite the approval of devices based on AI/big data 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 screening and designation system will be set up to simultaneously review the designation, verification, and evaluation of innovative medical devices, which were previously done sequentially. 

This 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 assessment so these applications can be done within a month. These applications were previously filed with different agencies, including the MFDS, the Health Insurance and Review Assessment, and the National Evidence-based healthcare Collaborating Agency.

Moreover, the evaluation of innovative medical devices is also being simplified to shorten the approval period by MFDS, which could take up to 250 days. The deliberation process will be minimised to two steps from the previous four to five steps; the deliberation committee will also just focus on three medical aspects of a device instead of 14. 


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

With the proposed changes, it is expected that the period from application to the 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 for three to five years as non-reimbursable or selective benefits devices. 

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


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

The medical devices market in South Korea has seen consistent growth throughout the past years. Last year, it grew to 9.1 trillion won ($6.8 billion), increasing by 21% year on year. By 2026, the market is projected to reach 12.3 trillion won ($10.9 billion), according to Fitch Solutions.


“We will resolve the situation where companies run around in sandbags, create a good working environment, and actively eliminate [cumbersome] regulations in the health and medical field to serve the public and the national interest,” said Lee Ki-il, second vice minister of Health and Welfare.

“We expect that the improvement of regulations on innovative medical devices will lead to the revitalisation 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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