The medical device and digital health industries are highly regulated, directly linked to FTAs and global certification standards (MDR, FDA, and ISO). Trade in AI diagnostic devices, telemedicine, and health data is expected to expand
between 2025 and 2026. Korea-EU, Comprehensive Plan for Transparency in Transparency Partnership (CPTPP), and CEPA are promoting procurement market expansion, mutual recognition of technology standards, and the easing of non-tariff barriers through medical device, pharmaceutical, and digital health provisions. However, the MDR (European Medical Device Regulation), GDPR, CBPR, and data protection laws pose major risks.
Risk factors | 2025-2026 Outlook | Influence (1~5) | Implications |
|---|---|---|---|
| MDR (European Medical Device Regulation) | Strengthening CE certification obligations | 5 | Simultaneous acquisition of CE and ISO13485 certification is required. |
| Data Protection Act | Restrictions on overseas transfer of patient data | 4 | GDPR and CBPR parallel certification required |
| Accessibility to procurement markets | Delay in easing public hospital bidding regulations | 3 | Actively utilize the FTA procurement chapter |
| Telemedicine Regulation | The tolerance range varies by country | 3 | Utilizing digital health provisions within the FTA |
| Supply Chain Risk | Dependence on imports of medical materials and components | 3 | Utilizing RCEP and CEPA cumulative origin |
FTAs offer practical benefits to the medical device industry beyond tariff reductions, including mutual recognition of certification , market opening, and digital health standardization
. The Korea-EU, CPTPP, and CEPA have streamlined export procedures through mutual recognition of medical device standards and clinical data, while
RCEP has relaxed country-of-origin cumulative criteria for parts, materials, and consumables , enhancing access to Asian markets .
field | FTA applicability | Major challenges | Management Points |
|---|---|---|---|
| Medical devices (HS9018) | Korea-EU, CPTPP, and RCEP | CE·FDA certification | MDR response and quality system reinforcement |
| Digital Health | CEPA·DEPA | Data protection regulations inconsistency | GDPR·CBPR two-factor authentication |
| Consumables/Parts | RCEP·CEPA | Complicated country of origin management | Use of cumulative origin criteria |
| public procurement | Korea-EU·CPTPP | Limited entry into the procurement market | Utilizing the Government Procurement Chapter |
Major export markets such as the EU, the US, and the UAE have different certification and data regulation systems, so
concluding a Mutual Recognition Agreement (MRA) under the FTA provisions is most effective.
market | Main items | MFN (basic rate) | When FTA is applied | Major non-tariff barriers | Comments |
|---|---|---|---|---|---|
| EU | Medical devices and health SW | 2~6% | 0% | MDR·GDPR | CE certification is required, data protection is important |
| USA | Medical devices and diagnostic equipment | 0~4% | FTA low rate | FDA·HIPAA | ITAR exclusion items are being expanded. |
| UAE | Medical and diagnostic devices | 5% | Phase-out through CEPA | local procurement | Visualizing the Real Effects of the Korea-UAE CEPA |
| japan | Health devices | 0~3% | RCEP application | PMDA certification | Standard Harmonization Progress |
| ASEAN | Consumer Goods Medical Devices | 3~8% | RCEP cumulative utilization | Customs clearance/standard deviation | Local partner cooperation is advantageous |
The healthcare industry is also strengthening data ethics, eco-friendly manufacturing, and supply chain transparency . The EU MDR is likely to require the disclosure of life cycle assessments (LCAs) and environmental indicators
at the manufacturing and distribution stages starting in 2026 .
System/Issue | Core requirements | Influence (1~5) | react |
|---|---|---|---|
| Health Data Ethics | Patient Data Protection and AI Transparency | 5 | Compliance with GDPR and AI Act |
| ESG procurement | Medical Device Supply Chain Transparency | 4 | ESG Reporting·ISO14001 |
| CBAM | Packaging and Material Carbon Emission Assessment | 3 | LCA·EPR management |
| MDR | CE certification + environmental information required in parallel | 4 | ISO13485+Environmental Management Integration |
| Telemedicine standards | Safety and security standards by country | 3 | Utilizing the FTA Digital Chapter |
Korea: Developing into an export hub focused on AI medical devices and diagnostic systems (Samsung Medison, Viewno, Lunit, etc.).
EU: CE certification costs increase with full implementation of MDR → FTA-based mutual recognition procedures are needed.
UAE: Opening of healthcare procurement market under CEPA, increasing demand for hospital clusters.
ASEAN: Rapid growth in diagnostic kit and wearable devices markets, driven by tariff reductions under RCEP.
US: Demand for telemedicine and digital health SaaS continues to grow, making HIPAA compliance essential.
Integrated analysis of the AI emotional index (α), the global health tech investment index (β), and industrial sentiment (λ). The medical device and digital health industries are expected to experience a gradual upward trend
in the fourth quarter of 2025, driven by increased exports of AI diagnostic devices .
variable | Δ(%) or exponent | analysis |
|---|---|---|
| ΔExport_now | +3.2 | Increase in exports of AI diagnostic devices and medical software |
| ΔImport_now | +1.7 | Increase in imports of raw materials and medical components |
| ΔPrice_now | +0.4 | Reflecting the increase in certification costs and component prices |
| ΔSignal_now | +0.041 | Positive industry news and investment spread |
| ΔFTAEffect | +0.39 | Strengthening the Effects of CEPA and RCEP |
| Forecast_3M | +0.65 | 3 months of gradual upward trend |
Formula (summary): Forecast_3M = 0.5·ΔSignal + 0.3·ΔFTAEffect + 0.2·ΔPrice
field | Suggestion | Executor | Expected effect |
|---|---|---|---|
| Certification and Standard Harmonization | Promoting mutual recognition agreements for CE, FDA, and ISO13485 | Ministry of Food and Drug Safety and Ministry of Trade, Industry and Energy | Reduce export costs |
| Data Ethics | Health Data AI Legislation Reform | Ministry of Health and Welfare and Ministry of Science and Technology | Enhancing global trust |
| public procurement | Expanding FTA-based medical device procurement | Ministry of Trade, Industry and Energy·KOTRA | Easy entry into export markets |
| ESG·MDR response | Introduction of an integrated environmental information certification system | Ministry of Environment and Ministry of Food and Drug Safety | Strengthening CBAM response |
| Global human resource development | Establishing a medical AI expert exchange system | Ministry of Health and Welfare·KOTRA | Strengthening technological competitiveness |
The medical device and digital health industries are leveraging the FTA's procurement, standards, and data ethics provisions
to reduce certification and export costs and secure market access.
Forecast_3M: +0.65 — AI diagnostics and digital health exports continue to grow.
Recommended strategies: ① Strengthening CE and FDA mutual recognition, ② Advancing GDPR and MDR response systems, ③ Strengthening ESG and data ethics management, and ④ Expansion centered on the CEPA and RCEP markets.
