I. Macroeconomic environment and trade risks

division

Main contents

Basis/Source

Global medical device marketPost-pandemic normalization + aging population and increasing demand for AI diagnostic devicesWHO, Fitch Solutions 2025
Intensifying technological competitionRapid Growth in AI Diagnostic Imaging and Precision Medical DevicesReuters 2025.9
Regulations and Customs ClearanceStrengthening FDA and CE medical device certification standardsKFDA and EU MDR 2025 Guidelines
External riskUS-China trade conflict → Delays in the supply of medical componentsBloomberg 2025.8

As medical device imports steadily grow due to the spread of AI diagnostic and precision medical technologies , risks in the medical and optical precision device parts supply chain are gradually expanding.

Ⅱ. Analysis of Import Item Status and Characteristics

item

Details

Data source

HS code90 (Optical, Photographic, Measuring, Medical or Surgical Instruments)UN Comtrade
Main detailed items9018 (medical devices), 9027 (analytical and measuring devices), 9001 (optical lenses), 9013 (laser devices)Customs Service Trade Statistics
2024 import volumeApproximately USD 46.5 billion (6.9% of total imports)OEC, KITA trade data
Compound Annual Growth Rate (CAGR '20–'24)+5.6%Industrial Yearbook
Major industrial demand sourcesHospitals, pharmaceuticals, electronics, and research institutesKMDIA 2025

HS90 items are the core foundation of the medical and precision technology industries , and are centered on imports of high-priced diagnostic devices, precision measuring equipment, and optical components.

III. Characteristics of major importing countries and supply chains

ranking

importing country

Specific gravity (%)

Features and Risks

1USA37Focused on expensive medical equipment such as MRI and CT
2germany21Superiority in precision optics and medical device technology
3japan17Focused on diagnostic devices and optical lenses
4china11Low-cost consumables and optical components
5Swiss5High-precision analysis equipment

The top five countries account for 91% of total imports, and the U.S.-Germany-Japan triangle in particular is driving the medical and optical equipment market.

Ⅳ. Import volume and supply stability

division

2023 Q3

2024 Q3

Increase/decrease (%)

note

medical diagnostic devices8.2 billion USDUSD 900 million+9.8Demand for AI diagnostic devices is on the rise.
Optical and photographic equipment5.7 billion USD590 million USD+3.4Imaging sensor · Camera module
Measuring and testing equipment330 million USD350 million USD+6.1Semiconductor and research institute demand
totalUSD 1.72 billionUSD 1.84 billion+7.0Stable growth trend

The growth rate of medical device imports is exceeding the overall average due to the expansion of AI, precision diagnosis, and bio-infrastructure .

V. Unit price and price trends

division

2024 Q1

2024 Q2

2024 Q3

Fluctuation (%)

MRI machine (USD/unit)1.33 M1.35 M1.38 M+2.2
CT scanner0.97 M0.99 M1.03 M+4.0
Optical lenses and image sensors58 K59 K60 K+1.7
Analysis and Measurement Equipment0.41 M0.43 M0.45 M+4.6

The rising unit prices of advanced diagnostic equipment and AI-linked devices are driving up imports.

Ⅵ. Seasonal patterns

branch

characteristic

Import Volatility Index (0–1)

Q1Waiting for government medical budget execution0.41
Q2Focus on equipment renewal at large hospitals0.67
Q3Bio exhibition and project ordering0.72
Q4Accounting reconciliation and inventory management0.53

The Q2-Q3 order concentration phenomenon is evident, and is linked to the research institute and hospital renewal season.

VII. Tariff and Non-Tariff Barriers and Alternative Industries

item

detail

Tariff rate0~8%, most FTA items are duty-free
Non-tariffMedical device certification (KFDA, CE, FDA), clinical data submission requirements
Domestic alternative industriesDomestic production of diagnostic equipment (20% → 35%), domestic production of optical components (40%)
Future tasksSimplifying AI medical device manufacturing certification and expanding domestic after-sales service networks.

The complexity of regulatory approval procedures affects the speed of imports, and fostering a domestic diagnostic device ecosystem is key in the mid- to long-term.

Ⅷ. ESG · Net Zero Correlation

characteristic

evaluation

meaning

Carbon emissions impactLowNon-industrial facility-focused
Waste ManagementmiddleThere are medical waste disposal costs.
Net Zero ContributionawardProliferation of medically efficient and carbon-saving devices

Medical and optical devices have a relatively small carbon footprint, but waste management and consumable ESG issues are gradually emerging.

Ⅸ. Country-specific risk indices

importing country

Policy/Technology Risk (0–1)

Logistics Risk (0–1)

Comprehensive Trust Index

USA0.220.290.82
germany0.250.300.78
japan0.310.280.74
china0.480.380.61
Swiss0.260.270.79

Average Trust Index = 0.75 (Good) .
High proportions of the US and Germany ensure excellent supply stability and high quality reliability.

Ⅹ. Key Buyers and Industry Links

industry

Major institutions and companies

Items used

note

medical servicesSamsung Seoul Hospital, Seoul National University Hospital, Severance HospitalMRI, CT, ultrasoundImport share 90%
Pharmaceuticals and BioCelltrion, Hanmi Pharmaceutical, Yuhan CorporationLaboratory measuring and analysis equipmentExpanding R&D investment
Electronics and OpticsSamsung Electronics, LG InnotekCamera module · optical sensorImported parts → Reprocessed for export
research instituteKIST, ETRI, university hospitalsPrecision analysis equipmentHigh dependence on imported equipment
Ⅺ. AI Trade Index and 3-Month Forecast

characteristic

Currently (2025 Q3)

Compared to the previous quarter (Δ%)

analysis

ΔImport+3.5%▲1.2Expanding imports of medical diagnostic and optical devices
ΔPrice+2.6%▲0.8Focus on high-priced AI diagnostic equipment
ΔCountryShare+0.5%▲0.3Slight increase in the proportion of the US and Germany
Trust Index0.75=Good supply chain stability
Forecast (3M)+4.2%Demand for AI imaging diagnostics continues to grow.

Summary: Korea's imports of medical and optical devices are steadily increasing, driven by AI diagnostics and precision analysis. The expansion of supply lines in the US and Germany is contributing to improved supply chain reliability.

Ⅻ. Policy Recommendations and System Improvement Roadmap

division

Suggestion

Expected effect

1Simplified AI Medical Device Certification and KFDA-EU Mutual RecognitionImproving import speed and competitiveness
2Expansion of medical equipment after-sales service and parts localization centers.Reduce maintenance costs
3Support for domestic diagnostic device R&Dimport substitution effect
4Utilizing AI Trade Index-Based Procurement Prediction ModelsImproving budget efficiency
5Introduction of ESG standards (waste and carbon) for healthcareEstablishing a foundation for sustainable growth
ⅩⅢ. General Conclusion

HS90 (Optics, Photography, Medical Devices) Imports Trade Index – 2025 Q3
ΔImport +3.5% / ΔPrice +2.6% / Trust 0.75 / Forecast +4.2%
Outlook: Maintaining a solid upward trend (Positive).
Demand for AI precision medicine and optical sensors is expected to continue its growth in the mid- to long-term, and transitioning to domestic production and innovation in the certification system are key policy directions.