1. Overseas industrial trends

The global optical and medical device market is growing rapidly, driven by an aging population, digital health, AI diagnostic technology, and increasing demand for optical sensors. South Korea's optical and medical device exports are projected to reach approximately USD 16.95 billion by 2024. Significance of using Trading Economics
: Understanding technological prowess, certification, and global regulatory changes directly contributes to strengthening the export competitiveness of Korean companies.

 

2. Major export items (based on intermediate classification HS)

Various optical, medical, and technical equipment are included as export items, with health devices, diagnostic equipment, optical lenses, and sensor modules being the mainstays.

division

HS code examples

Representative items

Strategy Points

Optical lenses and modulesHS90.01~90.10, etc.Camera modules, medical endoscope lensesResponding to high-precision and ultra-miniaturization demands
Diagnostic and testing equipmentHS90.21~90.24CT/MRI, ultrasound, blood analyzerMedical institution demand + R&D is important
Optical sensors and imaging equipmentHS85.42·90.28 AuxiliaryImage sensor, optical measuring instrumentSemiconductor, automobile, and medical convergence sectors
Medical machinery and equipmentHS84.14~84.17, etc.Surgical robots, rehabilitation devices, and medical automation equipmentFocus on high value-added and new markets

Recognizing strategic points for each product will help you plan your export product mix and technology investment direction.

3. Major exporting countries (size and characteristics by country)

Korea's optical and medical device exports are expanding, focusing on markets in North America, Europe, and Asia.

Country/Region

Strong items

Market characteristics

Implications

USADiagnostic and imaging equipment, surgical robotsStrong regulations on certification and health benefitsHigh-quality, high-function products are essential
Europe/UKOptical sensors, ophthalmic devicesStrengthening certification systems such as CE and MDRPre-certification and local response are important.
Southeast Asia and JapanOptical modules and medical device componentsGrowing into a manufacturing hubDemonstrating Korean companies' strength in parts supply
chinaMedical automation equipment and optical lensesFostering domestic industriesNeed to secure differentiation technology

Understanding the characteristics of each export destination country helps you develop entry strategies and manage risks.

4. Production volume / exportable volume

Although production volume measurement is complex, exportable volume is determined by technological capabilities, certification, delivery rate, and quality factors.

item

Number/estimate

unit

note

Export amount (2024)approximately USD 16.95 billionUSDTrading Economics
Domestic market sizeApproximately USD 7.11 billion (2024)USDFortune Business Insights
Exportable ratioEstimated at around 50-60%%Consider certification and scale restrictions

The production and export potential index can be used to determine the demand margin compared to supply capacity.

5. Quality standards

For high-precision optical and medical equipment, safety, precision, and reliability standards are very important.

field

Main specifications

note

Optical lenses and modulesISO 10110, ISO 13849Precision processing and machine safety standards
medical imaging equipmentIEC 60601, IEC 62304Electrical Safety and Software Verification
Optical sensors and measuring instrumentsISO 5725, ASTM E 112Measurement accuracy and reliability evaluation

Compliance with standards has a direct impact on export contracts, certification, and reliability.

6. Authentication

For medical and optical equipment, product certification is a prerequisite for market entry.

division

Certification name

Applicable area

medical devicesFDA 510(k) / CE MDRUS/Europe
optical equipmentISO 13485, IEC 60825Global
Information and communication convergenceIEC 62366, ISO/IEC 27001Digital medicine and sensor fusion

Obtaining certification is essential for entering new markets and securing competitiveness.

7. Logistics conditions

For high-priced, high-precision equipment, the logistics chain is important, from packaging and transportation to installation and post-service.

Product group

means of transportation

Average lead time

Key Risks

large medical equipmentSpecial packaging for air or sea20~40 daysInstallation delays, customs duties, and transportation damage
Optical modules and sensorsContainer/Aviation7~20 daysESD, temperature, and shock risks
Diagnostic devices and consumablesAviation5~15 daysUrgent delivery/quality damage

Understanding logistics conditions is essential for designing contract terms (FCA/CIF) and packaging and shipping strategies.

8. Minimum Order Quantity (MOQ)

High-value-added equipment and precision modules have small transaction units, high unit prices, and less standardization.

Product group

MOQ

unit

characteristic

large medical equipment1 Set or moreUnitsCustom production and installation required
Optical modules and sensors100 to 500 piecesDog (Units)Parts logistics and inventory management are important.
Diagnostic equipment and consumables1 Pallet or morePalletConsidering repeat deliveries and logistics efficiency

MOQ information helps you set sales terms, calculate costs, and develop inventory management strategies.

9. Data Deepening

Quantitative indicators such as unit price, seasonality, tariff risk, and ESG are analyzed and used to establish strategies.

cord

item

example

conjugation

(A)Unit price/transaction price rangeOptical lens unit price: USD ~200 ~ 500/piecePricing strategy and margin design
(B)Seasonal patternsMedical device purchases are expected to peak in Q3 and Q4.Establishment of production, delivery, and logistics plans
(C)Tariff and non-tariff risksResponding to the EU MDR Strengthening and US HS Code RevisionEstablishing an export market diversification strategy
(D)Domestic alternative industry dataIncreasing trend in the proportion of domestically produced medical devicesDesigning a parallel domestic and export strategy
(E)ESG·Net Zero CorrelationIncreasing demand for eco-friendly medical devicesOpportunities for developing differentiated products
(F)Country-specific risk indexUS/EU risk level 0.30Market Selection and Supply Chain Response Indicators
(G)List of major buyersGlobal hospital and AI medical device companyOverseas Sales and Partnership Design

The introduction of quantitative indicators will strengthen strategic decision-making in areas such as export planning, inventory management, and market selection.

10. Export Forecast Loop

We forecast export trends for the next three months, reflecting recent changes such as increased demand for digital health and optical sensors, and expanded investment in certification and facilities.

segment

ΔExport(%)

ΔPrice(%)

ΔCountryShare(pp)

TrustIndex(0–1)

3M Forecast

Optical lenses and modules+2.2%+0.7%+0.2 pp0.75Expected to see increased demand for smartphones and automotive optics.
Medical imaging and diagnostic equipment+1.0%+0.3%+0.1 pp0.70Continued demand for equipment replacement and aging population
Optical sensors and imaging devices+3.1%+1.1%+0.3 pp0.78Increasing convergence of AI health and automotive sensors

Forecast indicators are used as a practical information basis for export contracts, production adjustments, and logistics operations.