Ken Research Stated Vietnam's Medical Devices and Wearable Tech Market to Reached USD 2.5 billion

Comprehensive market analysis maps modernization-led growth trajectory, connected-health opportunities, and strategic imperatives for industry leaders across Vietnam's evolving healthcare-device ecosystem.

Delhi, India - October 31, 2025 - Ken Research released its strategic market analysis titled "Vietnam Medical Devices and Wearable Tech Market Outlook to 2030," revealing that the current combined market size is valued at USD 2.5 billion, based on a five-year historical analysis. The detailed study outlines how the market is poised to expand, driven by Vietnam's healthcare infrastructure modernization, rising demand for advanced diagnostic and monitoring devices, growing consumer adoption of health-focused wearables, and the convergence of device connectivity, telehealth platforms, and data-driven care models throughout the country.

The 100+ page report provides decision-makers with critical intelligence on market dynamics, competitive positioning, and investment opportunities across Vietnam's medical devices and wearable-tech value chain. Vietnam's smart wearables and broader consumer IoT wearables ecosystem is additionally estimated around USD ~1.1 billion, highlighting a robust on-ramp from wellness to medical use cases as reimbursement, clinical validation, and RPM pathways mature.

"Vietnam is at a pivotal point where device availability is translating into measurable clinical utility," said Namit Goel, Research Director at Ken Research. "Hospitals are upgrading diagnostics and monitoring while consumers adopt continuous health tracking-creating a bridge to remote patient monitoring and preventive digital care."

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Key Market Dynamics Reshaping Vietnam's Medical Devices & Wearables Landscape

Regulatory Modernization & Price Transparency

Vietnam's Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT define device classification (A-D), marketing authorization, local representative/MAH requirements, and mandatory price declaration on the MoH portal-reducing ambiguity, improving transparency, and supporting compliant market entry.

Hospital Infrastructure Upgrades

Public and private providers are investing in imaging, diagnostics, and patient monitoring. Third-party estimates place the core medical-devices market at ~USD 1.55-1.6 billion in 2024 with steady growth to 2030, aligning with Ken Research's broader ecosystem sizing. These upgrades create immediate demand for devices, consumables, and integration services.

Consumerization of Health & Medical-grade Wearables

Vietnam's consumer wearables base (smartwatches/trackers) forms the pipeline for clinical-grade adoption, with healthcare wearables sized around USD ~290 million and wearable medical devices projected to scale rapidly through 2030-2033. This underpins RPM, cardiometabolic tracking, and post-acute monitoring models.

Localization & Digital Infrastructure Opportunity

Vietnam's electronics manufacturing base and rising AI investments (e.g., FPT's AI centers/factories; planned mixed-reality hardware production) support local assembly, data localization, and AI-enabled diagnostics-improving time-to-market and customization for Vietnam's health system.

Critical Strategic Questions Addressed

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Market Entry Timing

With hospitals modernizing and consumer wearables adoption rising, the analysis identifies optimal entry points by device class (A-D), care setting (hospital, clinic, home), and wearables use case (wellness→medical-grade), noting accelerated uptake as regulatory clarity and integration pathways expand.

Regulatory Navigation

The mandate provides a practitioner's roadmap to Decree 98/2021 and Circular 05/2022: classification, MAC/registration, MAH requirements, price declaration, transitional provisions, and labeling-supporting audit-ready submissions and compliant commercialization.

Competitive Positioning

Benchmarking of leading multinational and regional players across imaging, diagnostics, patient monitoring, and wearables reveals portfolio breadth, pricing postures, channel strategies, and partnership structures to identify defensible positions as competition intensifies.

Investment Prioritization

White-space analysis highlights high-potential themes: remote patient monitoring, peri-operative and chronic-care monitoring, clinic-to-home connectivity, hospital diagnostics upgrades, and AI-assisted triage/reading-mapping capex needs, regulatory milestones, and localization levers.

Critical Infrastructure and Policy Developments

Regulatory Framework & Price Portal Enforcement

Decree 98/2021 mandates device price declaration and public posting, improving transparency for procurement and retail. Circular 05/2022 operationalizes procedures and documentation standards for classification and registration.

Import Licensing & Transitional Deadlines

End of derogations and full enforcement timelines (e.g., July 1, 2025, milestones) affect import licensure, ISO 13485/CFS requirements, CSDT adoption for higher-risk classes, and Vietnamese labeling-pressuring readiness for manufacturers and distributors.

Digital Health Enablement & Data Infrastructure

Vietnam's digital-health layer-telehealth, health informatics, AI-approaches USD ~0.9B scale, enabling data-driven devices and RPM models; concurrent AI/data-center investments strengthen on-shore compute for clinical applications and privacy compliance.

Hospital & Home-Care Connectivity

Integration of medical-grade wearables with EHR/telehealth workflows supports chronic-care pathways and post-discharge monitoring, lowering readmissions and expanding outpatient revenue pools.

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Strategic Value for Decision-Makers

"What distinguishes this analysis is its focus on actionable intelligence," noted Mr. Harsh Saxena, Principal at Ken Research. "Beyond market sizing, we map regulatory realities, partnership plays, and adoption patterns-giving executives a practical toolkit for compliant, accelerated entry."

The 100+ page mandate delivers essential market intelligence for executives and investors, including:

Detailed segmentation by device category (diagnostics, monitoring, therapeutic, consumables), risk class (A-D), care setting (hospital/clinic/home), and wearables type (smartwatch/fitness/medical-grade)

5- and 10-year forecast models with volume and revenue projections through 2030, with scenario analysis across regulatory and adoption milestones

Competitive benchmarking of leading global and regional players, including channel mix, pricing postures, partnerships, and pipeline visibility

White-space analysis in RPM, diagnostics modernization, AI-assisted imaging, supply-chain localization, and retail/pharmacy wearable channels

Regulatory roadmap covering Decree 98/2021, Circular 05/2022, subsequent amendments, price-declaration compliance, and import-licensing transitions

"As Vietnam's healthcare landscape digitizes, the convergence of medical technology and consumer wearables marks a transformative era in care delivery," added Harsh Saxena, Principal at Ken Research. "This analysis empowers decision-makers to identify high-growth opportunities, foster local innovation, and align business strategies with Vietnam's healthcare modernization agenda."

Industry executives seeking access to the complete analysis can contact Ken Research directly or visit:

https://www.kenresearch.com/vietnam-medical-devices-and-wearable-tech-market?utm_source=OpenPR&utm_medium=Referral&utm_campaign=PR

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Ankur Gupta
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Ken Research delivers strategic market intelligence that drives confident decision-making for industry leaders. With specialized expertise in high-growth markets across emerging economies, the firm provides data-driven insights that translate into competitive advantage for global organizations and investors.

This release was published on openPR.