Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).

MFDS Minister Eui-Kyung Lee told BioWorld that the AIMDs guideline will include “defining AI medical devices and the guidelines application, definitions of key terms after discussions with the other member countries … [the guidelines] will help secure the devices’ safety and effectiveness, assist in timely device launches and improve their quality.”

MDFS’s appointment of the AIMDs chairmanship would “increase [Korea’s] international credibility, as well as become an opportunity to introduce Korean-approved AI medical devices globally, and it would seek to work with the World Health Organization (WHO) and the International Electrotechnical Commission (IEC) to strengthen South Korea’s role in harmonizing medical device regulations globally, Lee added.

Launched in 2011, IMDRF is a voluntary group of medical device regulators from 10 countries harmonizing and optimizing regulations for medical devices globally. South Korea joined the group in December 2017, with the other member countries being Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, and the U.S.

Eui-Kyung Lee, MFDS Minister

Lee said that MFDS would put the experience of publishing the industry’s first global AI medical devices approvals and review guidelines in 2017 as a launching pad to work with the other IMDRF member countries in crafting the common guidelines. MDFS has since released six guidelines, under which 36 AI devices from 15 South Korean companies have been approved as of June 26.

Of the 36 devices, 22 were approved in 2020, with 2019 and 2018 seeing 10 and four devices approved respectively. Meanwhile, of the 37 devices currently in the clinical trials phase, 2020 accounted for 11 devices, while 2019 saw 17 devices, 2018 saw six, and 2017 saw five.

Domestically, MDFS enacted the Medical Devices Industry Development and Innovative Medical Devices Support Act on May 1. The ministry also enacted the In Vitro Diagnostic Medical Devices Act as well as a few other pieces of legislation supporting the medical industry on the same day. The act aims to support companies through the clinical trials and the approvals processes and aims to launch “safe products quickly by applying customized evaluations” said Lee.

The government’s Health Insurance Review and Assessment (HIRA) exempted medical devices from the mandatory Innovative Medical Technology Assessment process in March 2019. Eliminating the process, which could take up to 250 days, was a first step in faster device launches.

The Ministry of Healthcare and Welfare followed HIRA’s move by establishing a Separate Assessment Track for Innovative Medical Technology as a complement to the existing Innovative Medical Technology Assessment. Seoul-based Novomics Co Ltd. won marketing approval in November 2019 for the Nprofiler 1 stomach cancer assay, its molecular IVD assay kit, under the new separate track.

Although South Korea has made inroads since updating its industry regulations, MDFS will need to further eliminate structural barriers to move innovative medical devices onto the market.

MDFS has been keeping busy with a string of approvals in recent months. Seoul-based Vuno Inc. received MFDS approval in April for its Vuno Med-Lung CT AI, which uses AI to generate CT scans and detect early-stage lung cancer.

Meanwhile, Lunit Inc. received approval initial approval in August 2018 for Lunit Insight Mmg, the Seoul-based company’s AI software that analyzes mammography images to detect breast cancer. It went on to receive approval for the software’s use in Korea in July 2019.

Both companies are looking to take their devices overseas, with Vuno inking an agreement with Sony subsidiary M3 on June 19 to tap the Japanese market, and Lunit applying for FDA approval for its software after receiving European Commission approval on May 26.

Lee said that MFDA mostly permits software to be classed as medical devices that diagnose various diseases using medical images such as X-rays, CT and MR. Meanwhile, she added that products to diagnose diseases via biodata, such as medical images and electrocardiograms, are currently under development and in clinical trials. She declined to provide further details.

Meanwhile, MDFS granted urgent use approval to three novel coronavirus test kits under a path for use in emergency situations. SML Genetree’s Ezplex SARS-CoV-2 FAST Kit, Biosewoom’s Real-Q Direct SARS-CoV-2 Detection Kit and Labgenomic’s Labgun COVID-19 Fast RT-PCR Kit all received the MDFS green light and were picked from 13 applications submitted in May. The kits will primarily be used in emergency rooms as Korea continues to battle a second wave of COVID-19 cases. Thirty-three cases were reported in the country on July 14.

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