Vietnam

Medical Device Market Size

• Market Value: As of 2024, Vietnam’s medical device market is valued at approximately USD 1.7 billion, positioning it as the eighth-largest in the Asia-Pacific region.
• Growth Projections: The market is projected to reach USD 1.77 billion by 2025 and USD 2.47 billion by 2029, reflecting a Compound Annual Growth Rate (CAGR) of 8.62%.

Future Growth Potential

• Import Dependency: Over 90% of medical devices are imported, primarily from countries like China, South Korea, Japan, Germany, and the U.S.
• Aging Population: Vietnam’s aging population is increasing the demand for medical devices, especially those related to chronic disease management.
• Healthcare Infrastructure: The government is investing in expanding healthcare facilities, which is expected to boost the demand for medical equipment.

Registration Process

1. Regulatory Authority: The Ministry of Health (MOH), through the Infrastructure and Medical Device Administration (IMDA), oversees medical device regulation.
2. Device Classification: Medical devices are classified into four categories based on risk:
• Class A: Low risk
• Class B: Low to moderate risk
• Class C: Moderate to high risk
• Class D: High risk
3. Registration Requirements:
• Class A Devices: Require a Declaration of Applied Standards submitted to the local Department of Health.
4. Class B, C, and D Devices: Require a Marketing Authorization Certificate (MAC) obtained through submission to the MOH.
5. Local Representation: Foreign manufacturers must appoint a local authorized representative or Marketing Authorization Holder (MAH) to handle registration and liaise with regulatory authorities.
6. Technical Documentation: Submissions must include technical documentation, labeling, and, for Class C and D devices, a dossier in the ASEAN Common Submission Dossier Template (CSDT) format.
7. Quality Management System: Manufacturing facilities must have a valid ISO 13 485 certificate as part of the registration dossier.
8. Other Information

• Language Requirements: All documentation and labeling must be in Vietnamese.
• Online Portal: Registrations are managed through the MOH’s online portal: https://dmec.moh.gov.vn/
• Post-Market Surveillance: Manufacturers are required to monitor device performance and report adverse events as part of post-market obligations.