The government announced on Tuesday that it aims to establish Korea  as one of the top five medical device export powers by investing 10 trillion won ($7.6 billion) in research and development (R&D) of medical devices between 2023 and 2027, in collaboration with the private sector.

In addition, the government intends to broaden the evaluation and approval process to facilitate the entry of innovative domestic medical devices, including those that incorporate artificial intelligence (AI) and digital therapies, into the market expeditiously.

On Tuesday, the Ministry of Health and Welfare announced the 1st Comprehensive Plan for Fostering and Supporting the Medical Device Industry (2023~2027), which was developed in consultation with various stakeholders, including academia, researchers, and the medical community, to promote the growth of the medical device industry.

The plan marks the first mid- to long-term statutory comprehensive plan formulated under the Medical Device Industry Development and Innovative Medical Device Support Act, which came into effect in May 2020, to provide support for the development of the medical device industry.

The comprehensive plan outlines four strategies to encourage the introduction of new technologies to the market, which include increasing public-private investment in research and development (R&D), promoting the utilization of locally-produced medical devices, facilitating their entry into the global market, and expediting the market entry of cutting-edge technologies such as artificial intelligence (AI) and digital therapies.

Over the next five years, the government will prioritize enhancing export competitiveness by augmenting private and government investments in research and development (R&D) to 10 trillion won and providing support for strategic sectors.

The government will continue to support state-led research and development (R&D) efforts by concentrating on promising areas in the public sector and export fields, and by planning the second phase of the "Pan-Ministry Full-Cycle Medical Device R&D Project" following the first phase, which is slated to conclude in 2025.

To secure a greater share of the global medical device market, the government will increase its support for the development of high-volume export products such as in vitro diagnostic devices, imaging diagnostic devices, and dental materials. Additionally, it will invest in emerging technologies, such as digital health, medical robots, and implantable devices, to capture new markets.

The government will also provide support for investments in areas of public interest, such as aging, neglected medical conditions, and infectious disease response.

Also, it said it would streamline regulations related to the medical device industry to expedite the approval of new technologies, including the temporary approval of innovative products and the simplification of the clinical trial approval process.

In the short term, the government will broaden the scope of the “Integrated Review and Evaluation System for Innovative Medical Devices” and the “New Medical Technology Evaluation Deferral System” so that innovative medical devices can enter the market quickly.

In the mid-to long-term, medical devices utilizing new technologies will be introduced to the medical field without reimbursement after approval by the Ministry of Food and Drug Safety, and will be subjected to new medical technology evaluation when applying for health insurance.

In cases where innovative fields require technological advancement or essential medical treatments that have no alternatives, the government will consider providing temporary reimbursement for a period of one to three years to support the generation of evidence.

The comprehensive plan also includes revitalizing the use of locally-developed medical devices through clinical trials at home and abroad.

Recently, medical device regulations have been tightening in Europe and other countries. To respond to such a trend, the government plans to expand the currently operating Innovative Medical Device Demonstration Support Center (2020~2023) to respond to overseas regulations.

Aside from the center, regulatory officials plan to expand education and training centers and user evaluation projects so that Korean medical staff can directly use and verify locally-develop medical devices.

The plan will further support intensive support for establishing empirical data on new digital technologies and laying the foundation for clinical support and quality improvement in the field of in vitro diagnostics.

It will promote the pilot supply and clinical support of digital healthcare medical devices and establish a roadmap for the development of clinical evaluation and approval standards for digital medical devices.

“This comprehensive plan aims to foster the Korean medical device industry as a national strategic export business,” said Jung Eun-young, Director of Health Industry Policy at the Ministry of Health and Welfare,

From submission development to global market entry, the MOHW will actively support Korean medical devices to raise their status and create quality jobs, Jung added.