Vietnam Medical Device Registration
Vietnam is one of Southeast Asia’s most promising healthcare markets, with a projected medical equipment market size of approximately USD 1.77 billion in 2025. Fueled by a population of over 100 million, rising healthcare expenditure, and more than 13,000 public and private healthcare facilities, the Vietnamese market is an attractive destination for foreign manufacturers.
However, successful entry into this market depends on navigating the Vietnam medical device regulations enforced by the Ministry of Health under Decree 98/2021/ND-CP. Cisema offers full-service support for Vietnam medical device registration, guiding manufacturers through the entire registration process. We act as your Marketing Authorization Holder or Local Authorized Representative, enabling compliance and flexibility while maintaining control over your distribution and regulatory strategy.
Whether registering Class A and B diagnostics or high-risk Class C and D devices, our experts align your application with the ASEAN Medical Device Directive, providing risk classification, documentation support, and post-market compliance under evolving regulatory requirements. From import licenses and registration applications to post market vigilance and distributor updates, Cisema ensures your device registration in Vietnam is secure and successful.
Our Services for Vietnam Medical Device Registration
Cisema manages the full registration process for IVD and medical devices in Vietnam, working closely with the Vietnamese Ministry of Health (MoH) and the Department of Medical Equipment and Construction (DMEC).
Regulatory Strategy & Classification
Documentation Readiness & Feasibility Analysis
Regulatory Intelligence & Local Adaptation
Local Authorized Representative (LAR) Services in Vietnam
Under Vietnam’s medical device regulations, all foreign manufacturers of medical equipment and IVDs must appoint a Local Authorized Representative (LAR) to legally register and manage their products with the Ministry of Health (MoH). This requirement applies to all classes of devices, including Class A, Class B devices, Class C, and Class D medical devices. The LAR acts as your legal entity in Vietnam, responsible for regulatory communications, registration filings, post-market oversight, and ensuring alignment with the Vietnam medical device administration.
Cisema is fully licensed to act as your LAR in Vietnam. Our independent, non-commercial model allows you to retain full control over your product license, pricing, and local distributors while we manage your end-to-end regulatory responsibilities. This flexible approach supports scalable, multi-channel distribution without the need to change distributors or re-register your product.
Legal License Holder
Regulatory Affairs
Distributor Flexibility
Post-Market Vigilance
Global Coordination
Quality Control Inspection Services for Medical Equipment & IVDs in Vietnam
Cisema’s independent inspection services help ensure your products meet Vietnamese MoH requirements and international quality standards before market release. Our services align with ISO 13485, CE, and FDA expectations.
Incoming Goods Inspections
In-Process Quality Monitoring
Final Product Release Inspections
Special Inspection Projects
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
