Essential medical devices will be designated by next year

In addition to the designations being made for essential medicines in Korea

Digital Medical Products Act enacted in January this year… to manage clinical use and approval in one step

Expected to speed up clinical prescription by designating digital therapeutic devices as 'innovative medical devices'

The Ministry of Food and Drug Safety is considering establishing a system to designate national essential medical devices.

 

More specifically, the government plans to set a specific scope of medical devices that are essential for healthcare, such as rapid antigen test kits and life support devices that were necessary during COVID-19 but were difficult to supply stably through the market’s function alone.

 

Nam-hee Lee, Director-General of Medical Device Safety at MFDS

At a briefing with the MFDS’s correspondent journalists briefing, Nam Hee Lee, Director-General of the Pharmaceutical Safety Bureau at MFDS, said, "The need to designate essential medical devices has emerged as with pharmaceuticals amid the COVID-19 crisis.

 

However, no specific scope has been set for the medical devices, and it is necessary to discuss how to designate local or existing licensed medical devices, so we will need to conduct a study first." For pharmaceuticals, the Pharmaceutical Affairs Act defines national essential medicines, and the government has designated and is managing 448 items as national essential medicines as of 2024.

 

"There are frameworks set under the law to manage rare medical devices and medical devices subject to supply interruption reports, but the COVID-19 crisis has revealed global supply chain issues and that we rely on overseas import for many medical devices.

 

In part, we need to localize medical devices, and there are medical devices we have the technology for but are not produced due to profitably issues, so we need to study this." Various areas such as infectious disease treatment and life support devices are emerging as candidates for essential medical devices, and Lee said, "The concept of essential medical devices is expected to be similar to that of the essential medicines.

 

However, since there is no legal definition, we will conduct a research service this year and hope to see visible results by next year.” Another rising issue for MFDS this year is the ‘Digital Medical Products Act,’ which was enacted in January.

 

The Digital Medical Products Act covers not only digital medical devices with digital technologies such as digital sensors and mobile applications, but also digital medical and health support devices that apply digital technologies for medical support and health maintenance and improvement, and digital convergence medicines that combine these devices and medicines.

 

Under the act, a regulatory system for clinical trials, approval, and post-approval management has been established to efficiently and systematically evaluate the safety and efficacy of digital medical products based on digital characteristics such as the use of artificial intelligence and network connectivity.

 

(From the left) Sang Hyun Kim, Director of the Medical Device Management Division, Nam-Hee Lee, Director-General of the Pharmaceutical Safety Bureau, Hong-Mo Sung, Director of the Medical Device Policy Division, Seung-Young Lee, Director of the Innovative and Diagnostic Medical Devices Policy Division

Director-General Lee said, “We will prepare sub-statues so that digital medical products can be quickly commercialized.

 

It will be beneficial to the industry if our law can be used to promptly provide devices to the public and will position Korea as a global leader." Last year, the digital therapy devices Somzz’ and Welt's ‘WELT-I’ were designated as the first and second digital therapy devices.

 

However, it took more than 10 months from the approval to actual prescriptions, and it will take time for their reimbursement as the clinical outcome data has not been accumulated in hospitals.

 

Director-General Lee said, “The Ministry of Health and Welfare is thinking about various ways to improve the system, and has first decided to designate products as innovative medical devices to enable integrated review.

 

However, we are devising ways to enter the devices into the insurance system in some form, because reimbursement is possible only after the evaluation results of the product." However, when the next digital therapeutic devices, such as the third and fourth devices, are approved by the end of the year, Lee expected the innovative medical device designations to shorten the time to their prescriptions in the clinic first on a non-reimbursed basis.

 

If it is designated as an innovative medical device, it will be subject to an expedited approval review, which currently takes more than 600 days on average.

 

So I believe the clinical prescription period of the No.

 

3 product will be shortened further."