WHY DOMESTIC MEDICAL DEVICE MANUFACTURING IS AN INEVITABLE TREND
Amid ongoing disruptions in global healthcare supply chains, rising import costs, and increasingly stringent quality requirements, domestic medical device manufacturing is becoming an inevitable trend for many countries, including Vietnam. Beyond its economic significance, this shift plays a strategic role in ensuring healthcare security and fostering the sustainable development of national healthcare systems.
Made in Vietnam – Practical Value for the Healthcare System
Today, Made in Vietnam medical devices are no longer merely substitutes for imported products. With advancements in manufacturing technologies, research and development (R&D) capabilities, and quality management systems aligned with international standards, locally manufactured devices are progressively affirming their quality, safety, and suitability for Vietnam’s clinical practices.
Domestic production enables manufacturers to gain deeper insights into actual clinical needs, operating conditions, and disease characteristics. This understanding supports the development of medical devices that are closely aligned with real-world requirements, easy to deploy, and optimized for treatment effectiveness.
Supply Chain Autonomy
Recent global supply chain disruptions have highlighted the risks of excessive reliance on imported medical devices. Domestic manufacturing allows for greater supply autonomy, shorter lead times, and continuity in healthcare delivery—particularly for critical devices and consumables.
In addition, local manufacturers benefit from greater flexibility in adjusting production volumes, product configurations, and after-sales services, enabling them to respond rapidly to the evolving needs of healthcare facilities.
Figure 1: Domestic manufacturers benefit from flexibility in adjusting production capacity and product configurations
Quality Control
Local medical device manufacturing allows enterprises to exercise comprehensive control over the entire product lifecycle—from design and material selection to manufacturing, testing, and distribution. These processes are established and operated in accordance with stringent standards such as ISO, GMP, and other relevant regulations, ensuring safety, stability, and traceability.
Figure 2: Domestic manufacturing enables full lifecycle quality control
Proactive quality control not only enhances corporate credibility but also strengthens trust among hospitals, physicians, and regulatory authorities.
Sustainable Value for Vietnam’s Healthcare Sector
Domestically manufactured medical devices deliver long-term benefits to the national healthcare system, including:
- Reduced dependence on imported products
- Optimized investment and operating costs for hospitals
- Promotion of supporting industries and high-skilled technical workforce development
- Enhanced national healthcare self-reliance
In the long term, these advantages form a critical foundation for Vietnam to integrate more deeply into regional and global medical device value chains.
USM Healthcare – CDMO Capabilities in Medical Device Manufacturing
In line with the localization trend in medical device manufacturing, USM Healthcare positions itself as a Contract Development & Manufacturing Organization (CDMO), with a focus on cardiovascular and interventional medical devices as well as minimally invasive solutions.
Leveraging its R&D expertise, manufacturing infrastructure, and internationally compliant quality management systems, USM Healthcare delivers end-to-end services—from concept development, design, and testing to production and product commercialization. The CDMO model accelerates time-to-market while ensuring strict compliance with regulatory, quality, and clinical performance requirements.
Figure 3: USM Healthcare provides end-to-end services from concept development to commercialization
Investment in domestic medical device manufacturing is a long-term strategy that requires sustained commitment to quality and technological innovation. Guided by a sustainable development vision, USM Healthcare continues to strengthen its manufacturing capabilities in line with international standards, aiming to effectively serve the domestic market while progressively integrating into the global medical device supply chain.
Author: Compiled from multiple sources./.
Bộ Y tế. (2023). Quy định thủ tục liên quan thiết bị y tế nội địa. Bộ Y tế Việt Nam. Truy cập từ https://ngaigiao.chauduc.baria-vungtau.gov.vn/uploads/files/1745196071_1292%20quyet%20dinh%20cong%20bo%20sua%20doi%20bo%20sung%20tthc%20final.signed-1.pdf
Chính phủ Việt Nam. (2024). Phát triển công nghiệp trang thiết bị y tế sản xuất trong nước. Báo Chính phủ. Truy cập từ https://baochinhphu.vn/phat-trien-cong-nghiep-trang-thiet-bi-y-te-san-xuat-trong-nuoc-102276530.htm
Pháp Luật TP.HCM. (2024). Vật tư y tế trong nước: Thách thức sản xuất & cạnh tranh thị trường. Báo Pháp Luật TP.HCM. Truy cập từ https://plo.vn/vat-tu-y-te-trong-nuoc-kho-vi-dau-tu-lon-nhung-gia-ban-ra-phai-thap-post805521.html
Thanh Niên. (2024). Thiết bị y tế sản xuất trong nước cạnh tranh khốc liệt với hàng nhập khẩu. Thanh Niên. Truy cập từ https://thanhnien.vn/thiet-bi-y-te-san-xuat-trong-nuoc-canh-tranh-khoc-liet-voi-hang-nhap-khau-185240816184151713.htm
StartUs Insights. (2025). Medical equipment manufacturing industry trends. StartUs Insights. Truy cập từ https://www.startus-insights.com/innovators-guide/medical-equipment-manufacturing-industry-trends/
Medical Product Outsourcing. (2025). Medtech’s supply chain: global risks driving regional manufacturing. MPO Magazine. Truy cập từ https://www.mpo-mag.com/medtechs-supply-chain-global-risks-driving-regional-manufacturing/
Reuters. (2025, September 25). U.S. medtech stocks fall as administration opens import probe. Reuters. Truy cập từ https://www.reuters.com/business/healthcare-pharmaceuticals/us-medtech-stocks-fall-trump-administration-opens-import-probe-2025-09-25/




