This video breaks down the MOH’s regulatory framework, device classification (Classes A–D), and the critical role of a Marketing Authorization Holder (MAH) in securing market access. Learn how expert guidance can help you fast-track approvals and tap into one of Southeast Asia’s most dynamic medtech markets.
This video gives foreign medical device manufacturers a clear, step-by-step guide to entering Vietnam’s $2.47 billion medical device market, which is projected to grow 8.62% annually through 2029. The in vitro diagnostics (IVD) segment alone is expected to reach $1.90 billion, growing at 4.65% CAGR. Demand is driven by Vietnam’s nearly 100 million residents, rapid GDP growth, and government incentives to modernize the healthcare system, alongside an aging population, rising healthcare spend (6.6% of GDP), and the country’s heavy reliance on imports for roughly 90% of its medical devices.
Topics Covered in This Video:
The country’s medical device regulatory framework is overseen by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH). Devices are classified into four categories—Class A (lowest risk) through Class D (highest risk)—with requirements scaling by risk level. For Class A devices, a notification to the provincial Department of Health is sufficient, but Class B, C, and D devices require a comprehensive technical dossier and may benefit from fast-track pathways.
Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) to act as their in-country regulatory representative. The MAH is responsible for managing all submissions, liaising with Vietnamese authorities, ensuring compliance with post-market regulations, and overseeing license renewals. Choosing a qualified MAH is critical to avoiding delays and compliance issues.
Ready to start selling in Vietnam?
Partnering with an experienced regulatory consultancy can dramatically shorten approval timelines and reduce administrative burdens. Pure Global’s Ho Chi Minh City–based team combines on-the-ground expertise with AI-driven dossier tools to accelerate the classification, documentation, and registration process. As your MAH, we ensure seamless communication with IMDA, maintain ongoing compliance, and leverage a single registration process to expand your reach across multiple ASEAN markets. Learn more about MOH Vietnam Medical Device Registration.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us