Health check Vietnam: Opportunity for MedTech and private healthcare investors

A leading European in vitro diagnostic (IVD) manufacturer sought to establish a wholly foreign-owned subsidiary in Ho Chi Minh City, Vietnam. The company needed to navigate complex regulatory procedures including import licensing, VAT exemptions for clinical devices, and full registration with the Ministry of Health. The challenge was to accomplish this efficiently while ensuring full compliance with Vietnam's regulatory framework for medical devices and diagnostic equipment.

In 2023, Ecovis advised the European IVD manufacturer on establishing a wholly foreign-owned subsidiary in Ho Chi Minh City. The solution involved successfully navigating import licensing procedures, VAT exemptions for clinical devices, and full registration with the Ministry of Health. Ecovis was able to draw on its many years of expertise in the regulatory approval and registration of medical devices at the Ministry of Health, its experience in structuring public-private joint ventures for hospital chains, and in tax optimisation for diagnostic companies that import AI-based screening tools. The implementation was completed within less than 4 months.

The European IVD manufacturer successfully established its wholly foreign-owned subsidiary in Ho Chi Minh City within less than 4 months. The company achieved full compliance with all regulatory requirements including import licensing, VAT exemptions for clinical devices, and registration with the Ministry of Health. This efficient establishment positioned the company to participate in Vietnam's growing medical device market, which is valued at USD 1.68 billion in 2024 and projected to reach USD 2.5 billion by 2030 with a compound annual growth rate of 10.2%.