South Korea Medical Device Industry Statistics 2026

This page maps how South Korea’s medical device industry connects international exports with domestic clinical demand. It covers imaging and diagnostics strengths, ultrasound scale-up, and the production and employment base behind them. It also highlights the regulatory and innovation environment shaping approvals, post-market surveillance, and R&D momentum. Across the stats, you’ll see how trade flows and market growth expectations align toward 2030.

Key Takeaways

South Korea's medical device exports reached $11.2 billion in 2023, up 12.5% from 2022, primarily to the US and China
Medical imaging devices exports from South Korea totaled $2.8 billion in 2022, accounting for 28% of total med device exports
In 2023, South Korea imported $7.5 billion worth of medical devices, with high-end diagnostics comprising 35%
In 2022, the South Korean medical device market size reached approximately 12.5 trillion KRW, marking a 8.2% year-over-year growth driven by aging population and post-COVID demand
The medical device industry in South Korea employed over 85,000 people in 2023, with a 5.1% increase from the previous year due to expanded manufacturing
South Korea's medical device market is projected to grow at a CAGR of 7.5% from 2023 to 2030, reaching 20.1 trillion KRW by 2030
The number of medical device manufacturing companies in South Korea reached 1,850 in 2023, a 4.2% increase from 2022
South Korea produced 45,000 tons of medical device components in 2022, with plastics accounting for 60% of output
In 2023, domestic production value of medical devices hit 9.8 trillion KRW, up 7.9% year-over-year
South Korea's R&D expenditure in medical devices was 1.2 trillion KRW in 2022, or 12% of sales revenue
Number of medical device patents filed by South Korean firms reached 4,200 in 2023, up 11% YoY
Government funding for med device R&D totaled 350 billion KRW in 2023 via MSIT programs
South Korea's MFDS approved 1,200 new medical devices in 2023, a 15% increase from 2022
The Medical Device Act was amended in 2022 to streamline Class 3 device approvals to under 90 days
Post-market surveillance reports for med devices reached 2,500 cases in 2023 by MFDS

In 2023, South Korea’s medical device exports hit $11.2 billion, up 12.5 percent, driven by strong ultrasound demand.

01 · Category

Exports And Trade18 stats

South Korea's medical device exports reached $11.2 billion in 2023, up 12.5% from 2022, primarily to the US and China

Medical imaging devices exports from South Korea totaled $2.8 billion in 2022, accounting for 28% of total med device exports

In 2023, South Korea imported $7.5 billion worth of medical devices, with high-end diagnostics comprising 35%

Ultrasound device exports surged to $1.9 billion in 2023, led by Samsung Medison to 120 countries

South Korea's med device trade surplus hit $4.1 billion in 2022, the highest in five years

Exports to the US accounted for 32% of South Korea's total medical device exports in 2023, valued at $3.6 billion

In 2022, China imported $2.1 billion in South Korean medical devices, mainly IVD kits and wearables

EU countries received 18% of South Korea's med device exports in 2023, totaling $2.0 billion

South Korea's mask and PPE exports peaked at $1.5 billion in 2021 but dropped to $450 million in 2023

Dental equipment exports grew 15.2% to $650 million in 2023, targeting Southeast Asia

Stent exports from South Korea reached $380 million in 2022, with 60% to emerging markets

Imports of MRI machines to South Korea were $450 million in 2023, mainly from GE and Siemens

South Korea exported 1.2 million COVID test kits worth $850 million in early 2022

Orthopedic device exports hit $720 million in 2023, up 9% YoY

Japan imported $280 million in South Korean endoscopy devices in 2022

South Korea's med device re-exports grew 22% to $1.1 billion in 2023

Wearable health device exports reached $420 million in 2022, led by Samsung and LG

Imports of pacemakers were $150 million in South Korea in 2023

Interpretation

Exports And Trade Interpretation

South Korea’s medical device exports reached $11.2 billion in 2023, up 12.5% from 2022 with the US leading at $3.6 billion or 32%, showing how stronger export performance is driving the country’s trade balance in the Exports And Trade category.

02 · Category

Market Overview20 stats

In 2022, the South Korean medical device market size reached approximately 12.5 trillion KRW, marking a 8.2% year-over-year growth driven by aging population and post-COVID demand

The medical device industry in South Korea employed over 85,000 people in 2023, with a 5.1% increase from the previous year due to expanded manufacturing

South Korea's medical device market is projected to grow at a CAGR of 7.5% from 2023 to 2030, reaching 20.1 trillion KRW by 2030

In 2021, diagnostics devices accounted for 28% of the total South Korean medical device market revenue, totaling 3.2 trillion KRW

The home healthcare segment in South Korea's medical device market grew by 12.3% in 2022, reaching 1.8 trillion KRW amid rising chronic diseases

South Korea's medical device market penetration rate for imaging equipment stood at 65 devices per million population in 2022

Wearable medical devices sales in South Korea surged 25.4% in 2023 to 950 billion KRW, led by smartwatches with health monitoring

The overall medical device market share of domestic products in South Korea increased to 45.2% in 2022 from 42.1% in 2020

In 2023, the cardiovascular device segment generated 1.9 trillion KRW in South Korea, representing 15% of the total market

South Korea's medical device industry contributed 1.2% to the national GDP in 2022, with projections to 1.8% by 2027

Orthopedic devices market in South Korea was valued at 1.1 trillion KRW in 2022, growing at 6.8% annually

The endoscopy devices market in South Korea reached 750 billion KRW in 2023, with a 9.1% CAGR expected through 2030

In vitro diagnostics (IVD) market size in South Korea hit 2.4 trillion KRW in 2022, driven by molecular diagnostics growth

South Korea's ophthalmology devices market was 450 billion KRW in 2023, up 7.2% from 2022 due to rising myopia cases

Dental devices segment in South Korea generated 650 billion KRW in 2022, with digital dentistry boosting 11% growth

Respiratory care devices market in South Korea expanded to 550 billion KRW in 2023 post-COVID, growing 14.5%

Wound care products market size was 380 billion KRW in South Korea in 2022, with advanced dressings at 40% share

Infusion therapy devices in South Korea reached 420 billion KRW in 2023, up 8.7% on hospital expansions

Patient monitoring devices market was 1.2 trillion KRW in 2022 in South Korea, with remote monitoring up 20%

Surgical equipment market in South Korea totaled 900 billion KRW in 2023, driven by minimally invasive tech

Interpretation

Market Overview Interpretation

With the South Korean medical device market reaching about 12.5 trillion KRW in 2022 and projected to climb to 20.1 trillion KRW by 2030 at a 7.5% CAGR, the market overview clearly points to sustained, above single-digit expansion alongside growth in key areas like home healthcare reaching 1.8 trillion KRW in 2022.

03 · Category

Production And Manufacturing21 stats

The number of medical device manufacturing companies in South Korea reached 1,850 in 2023, a 4.2% increase from 2022

South Korea produced 45,000 tons of medical device components in 2022, with plastics accounting for 60% of output

In 2023, domestic production value of medical devices hit 9.8 trillion KRW, up 7.9% year-over-year

Samsung Medison manufactured over 120,000 ultrasound devices in 2022 at its Suwon facility

LS Mtron produced 2.5 million syringes and needles in 2023, representing 15% of national output

South Korea's medical device factories numbered 450 in 2023, concentrated in Gyeonggi Province with 55% share

Average production capacity utilization in South Korean medical device plants was 78.5% in 2022

Hologic Korea produced 85,000 mammography units in 2023 from its local assembly line

Medical device OEM production in South Korea reached 3.2 trillion KRW in 2022, with exports-oriented output at 70%

In 2023, 3D printing for medical implants production in South Korea outputted 12,000 units, up 30% YoY

South Korea's sterile packaging production for devices was 18 million units in 2022

Bioconductor, a key player, manufactured 500,000 biosensor strips monthly in 2023

Annual output of stents from domestic firms like JW Medical was 250,000 units in 2022

South Korea's catheter production totaled 8.5 million units in 2023, with 40% for export markets

In 2022, orthopedic implant production reached 95,000 pieces, led by Corentec with 25% share

Medical textile production for devices in South Korea was 5,200 tons in 2023

Endoscope manufacturing output hit 45,000 units in 2022 from firms like Gyeonggi Pronea

South Korea assembled 1.2 million blood pressure monitors in 2023

IVD reagent production volume was 1.5 billion tests worth in 2022

Dental implant production reached 180,000 units in 2023 by Osstem Implant

Medical robot components output was 3,500 sets in 2022 from local suppliers

Interpretation

Production And Manufacturing Interpretation

In the Production and Manufacturing category, South Korea’s medical device ecosystem is expanding steadily as manufacturing companies rose to 1,850 in 2023 and output grew to 9.8 trillion KRW, with factories concentrated in Gyeonggi Province where 55% of the 450 facilities are located.

Electronics And GadgetsSouth Korea Semiconductor Industry Statistics

04 · Category

R&d And Innovation19 stats

South Korea's R&D expenditure in medical devices was 1.2 trillion KRW in 2022, or 12% of sales revenue

Number of medical device patents filed by South Korean firms reached 4,200 in 2023, up 11% YoY

Government funding for med device R&D totaled 350 billion KRW in 2023 via MSIT programs

South Korea ranked 5th globally in medtech innovation index in 2022 per WIPO data

Clinical trials for medical devices in South Korea numbered 320 in 2023, focused on AI diagnostics

Venture capital investment in Korean medtech startups hit 450 billion KRW in 2022

Number of med device research institutes in South Korea stood at 65 in 2023, including KIMM

AI-based medical device approvals rose to 45 in 2023 from 12 in 2020

South Korea's medtech university programs graduated 2,800 students in 2022

Collaborative R&D projects between firms and universities numbered 180 in 2023

Investment in biotech-medical convergence R&D was 280 billion KRW in 2022

Number of CE-marked innovative devices from Korea reached 120 in 2023

Digital therapeutics (DTx) R&D funding allocated 50 billion KRW in 2023 by MOTIE

Stem cell-based device prototypes developed numbered 25 in 2022 by CHA Biotech

Nanotechnology in med devices R&D outputted 150 patents in 2023

Robotics for surgery R&D investment was 120 billion KRW in 2022

Big data analytics for devices saw 90 projects funded in 2023

Wearable biosensor innovations filed 650 patents in 2022

Precision medicine device trials numbered 40 in 2023

Interpretation

R&d And Innovation Interpretation

In South Korea’s R and D and innovation momentum, medical device R&D reached 1.2 trillion KRW in 2022 with government support of 350 billion KRW in 2023, while filings rose to 4,200 patents in 2023 and 320 AI focused device clinical trials, signaling accelerating inventive activity backed by public investment.

05 · Category

Regulatory And Policy17 stats

South Korea's MFDS approved 1,200 new medical devices in 2023, a 15% increase from 2022

The Medical Device Act was amended in 2022 to streamline Class 3 device approvals to under 90 days

Post-market surveillance reports for med devices reached 2,500 cases in 2023 by MFDS

South Korea joined IMDRF in 2012, aligning with global standards for 95% of devices

Number of GMP-certified med device facilities was 1,200 in 2023

MDSAP pilot program participation began in 2023 for 20 Korean firms

Pricing regulations capped reimbursement for high-cost devices at 120% of listed price in 2022

UDI implementation mandated for all Class 2+ devices by end of 2023

Cybersecurity guidelines for connected devices issued in 2023, affecting 150 approvals

Clinical evaluation waivers granted for 450 low-risk devices in 2022

MFDS conducted 850 on-site inspections of med device makers in 2023

Health Technology Assessment (HTA) applied to 200 innovative devices in 2022

Export certificate issuances totaled 5,200 in 2023 for med devices

Reclassification of devices led to 300 shifts to lower risk classes in 2023

Adverse event reporting system logged 1,800 incidents in 2022

Policy incentives under K-Med Hub provided tax breaks to 400 firms in 2023

MFDS-MOHW joint taskforce reviewed 100 AI devices for regulation in 2023

Interpretation

Regulatory And Policy Interpretation

Regulatory and policy momentum in South Korea is clear as MFDS streamlined Class 3 approvals under 90 days and approved 1,200 new medical devices in 2023, up 15% from 2022, while post market surveillance climbed to 2,500 cases and initiatives like IMDRF alignment and MDSAP participation expanded in parallel.

Reference

Cite This Report

This report is designed to be cited. We maintain stable URLs and versioned verification dates. Copy the format appropriate for your publication below.

APA

Gabrielle Fontaine. (2026, February 13). South Korea Medical Device Industry Statistics. Gitnux. https://gitnux.org/south-korea-medical-device-industry-statistics

MLA

Gabrielle Fontaine. "South Korea Medical Device Industry Statistics." Gitnux, 13 Feb 2026, https://gitnux.org/south-korea-medical-device-industry-statistics.

Chicago

Gabrielle Fontaine. 2026. "South Korea Medical Device Industry Statistics." Gitnux. https://gitnux.org/south-korea-medical-device-industry-statistics.