Building medical device law aligned with global practices

Vietnam’s medical device market is potential yet vulnerable. Vietnam is one of the fastest-growing medical device markets in the region. The local market size was $1.8 billion in 2024, with 90 per cent of medical devices imported, indicating significant reliance on global supply chains.

Particularly, members of our committee as well as those of EuroCham Vietnam as a whole account for 85 per cent of the market share, ensuring a stable and high-quality supply for the healthcare system.

However, the industry faces significant challenges as the government is drafting the first medical device law in Vietnam. This law could either drive the sector forward or become a barrier if not aligned with international best practices.

We appreciate the Ministry of Health’s (MoH) efforts in drafting the law, but there are key issues to address. They include a lack of personnel and expertise in medical device policymaking.

If the law does not align with international standards, it will create burdens for both businesses and regulatory authorities.

Most importantly, patients will suffer from limited access to advanced technologies. We believe that a good law is one that is practical and enforceable. If the law is built on international harmonisation, ensuring transparency and clear post-market surveillance, it will serve as a golden opportunity to enhance regulatory efficiency, enable better market control, and attract investment in the healthcare sector. This benefits the economy in the long run, builds business confidence, and fosters the adoption of advanced technologies.

We recommend that the medical device law should be aligned with international standards to ensure transparency and effective post-market surveillance, and create policies that enhance regulatory efficiency and draw in investment.

We are ready to share best practices through experience exchange and support the MoH in strengthening legal capacity.

On another note, value-based procurement is a global necessity. In addition to the medical device law, healthcare procurement policies, especially centralised procurement, need to be addressed. Prioritising low prices over quality could limit access to advanced technologies, innovation and increase long-term costs.

We believe that value, not price, should be the core factor in healthcare procurement. This is not just a global trend, but also a sustainable solution that brings long-term benefits to the healthcare system and society.

Many countries have adopted value-based procurement, leading to better healthcare outcomes and cost savings. For instance, India saved around $2 million annually on cardiovascular stents; the UK saved $50 million over five years on hip and knee implants; and the US saved $70 million annually on cardiac pacemakers.

We recommend excluding high-tech devices from centralised procurement, focusing on value-based procurement, and integrating this framework into law.

Vietnam has a unique opportunity to shape the future of its medical device sector. A progressive law and effective procurement policies will drive technological innovation, improve healthcare quality, and protect patients’ rights.