VietnamVietnam's life-sciences sector is one of Southeast Asia's fastest-growing, driven by a rising middle class, expanding universal healthcare coverage, and a government committed to modernising its pharmaceutical and medical device industries. Taevas provide
Select an industry to see regulatory pathways, services, and how Taevas supports your Vietnam market entry.
Drug Administration of Vietnam (DAV) and the Department of Medical Equipment and Construction (CQTBYT) under the Ministry of Health Vietnam
Vietnam's medical device market is valued at over USD 1.1 billion and growing at approximately 15% annually, fuelled by hospital infrastructure investment and rising chronic disease prevalence. All medical devices must be registered with the Drug Administration of Vietnam under Decree 98/2021/ND-CP and its amendments, with classification ranging from Class A (lowest risk) to Class D (highest risk). Taevas manages the full registration lifecycle, from technical dossier preparation to post-market surveillance, ensuring your devices are compliant and commercially ready across Vietnam's 63 provinces.
Taevas classifies your device under Vietnam's Class A-D framework per Decree 98/2021/ND-CP and prepares a complete technical dossier aligned with DAV requirements, including conformity declarations and clinical evidence summaries.
We submit your registration application to the Drug Administration of Vietnam and manage all correspondence until a valid circulation number (so dang ky) is issued, which is mandatory before any commercial sale or import.
Securing an import licence from the Ministry of Health is a prerequisite for bringing devices into Vietnam; Taevas coordinates with licensed importers and customs brokers to ensure seamless clearance at port.
Vietnam requires ongoing adverse event reporting and periodic renewal of circulation numbers; Taevas maintains your compliance calendar and submits renewal dossiers before expiry to avoid market disruption.
Taevas has guided international life-sciences brands through every stage of Vietnam market entry, combining deep MOH regulatory expertise with an on-the-ground commercial network that spans all 63 provinces.
Our Vietnam regulatory team has direct experience navigating DAV, VFA, and CQTBYT requirements across medical devices, pharmaceuticals, cosmetics, and functional foods, ensuring your dossiers are submission-ready and compliant from day one.
With offices and operational partners in both Hanoi and Ho Chi Minh City, Taevas provides genuine on-the-ground coverage of Vietnam's northern and southern markets, including direct access to provincial health departments and hospital procurement committees.
Our pre-built regulatory templates, established DAV submission workflows, and existing importer relationships allow us to compress typical Vietnam registration timelines significantly, getting your products to market faster than a standalone entry approach.
Taevas maintains vetted relationships with leading pharmaceutical distributors, medical device dealers, pharmacy chains, and key opinion leaders across Vietnam's major clinical specialties, giving your brand immediate commercial reach from launch.
Our Vietnam team includes regulatory affairs specialists, medical affairs managers, commercial directors, and logistics coordinators who work exclusively in the life-sciences sector and understand the nuances of Vietnam's evolving healthcare landscape.
Taevas has successfully supported market entry programmes across the full Southeast Asian region, and our Vietnam practice benefits from cross-market intelligence that helps global brands anticipate regulatory shifts and commercial trends before they impact strategy.
Whether you are registering a medical device with DAV, launching a pharmaceutical brand, or entering Vietnam's booming wellness market, Taevas delivers the regulatory expertise, commercial networks, and operational infrastructure to take you from application to revenue.