Vietnam Medical Device Registration
Important Notes
- MOH & DAV Mandatory Circulation License: All medical devices require a Circulation License issued by the Ministry of Health or the Drug Administration.
- Risk-Based Classification System: Medical devices are classified into Class A, B, C, D based on risk level, with differentiated registration pathways and technical requirements.
- Local License Holder System: A foreign manufacturer must appoint a locally incorporated Vietnamese company as the Circulation License holder, assuming all registration and market liabilities.
- Mandatory Vietnamese Documentation & Labeling: All technical dossiers, labels, and instructions must be in Vietnamese, strictly complying with local regulations and pharmacopoeia standards.
- Price Declaration & Health Insurance Listing: Medical device prices must be declared. Inclusion in the National Health Insurance reimbursement list is key for public hospital market share.
- Growing Emphasis on Local Clinical Trial Data: For high-risk medical devices, regulators increasingly prefer or strongly recommend local clinical trial data involving Vietnamese populations.
Vietnam Specific Requirements
- One of Southeast Asia's Fastest-Growing & Most Dynamic Markets: A large, young population, rapid economic growth, and rising health expenditure make it a strategic priority for medical device multinationals.
- Accelerated Regulatory Reform & Modernization: The DAV is actively aligning medical device regulations with international standards and optimizing e-registration, though inconsistencies may arise during transition.
- Public Hospital Dominance with Rapid Private Channel Growth: Public hospitals remain primary medical device procurement points, but private hospitals and clinic chains are growing much faster.
- Active ASEAN Member & Beneficiary of Manufacturing Shift: Vietnam actively participates in ASEAN harmonization for medical devices and is becoming a key regional manufacturing base due to cost advantages and FTAs.
- Strategic Gateway to Southeast Asian Medical Device Markets: Vietnam's well-developed infrastructure, central location, and trade-friendly policies make it an ideal regional hub for medical device distribution and market expansion.
Medical Devices Registration
Regulatory Requirements
- Medical Device Marketing Authorization
- Classification Management by Risk Level (Class A, B, C, D)
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- Vietnamese Labeling and Instructions for Use
- Free Sale Certificate
- Clinical Evaluation Report
- Product Technical File
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Representative Appointment
- MOH Application Submission
- Technical Review
- Marketing Authorization Acquisition
Registration Timeline
9-18 months
Official Fees
VND 30,000,000 - 500,000,000
Service Fees
$16,000 - $45,000
Regulatory System Overview
MOH Vietnam
Ministry of Health Vietnam
Responsible for medical device registration approval, quality supervision, and market regulation. Serves as the supreme medical device regulatory authority in Vietnam.
DAV
Drug Administration of Vietnam (DAV)
Responsible for specific medical device registration approval, technical review, and post-market surveillance under the Ministry of Health.
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Vietnam medical device regulations (Class A-D)
Technical Documentation Preparation
Prepare complete Vietnamese technical documentation including product specifications, test reports, clinical data
Local Representative Appointment
Appoint authorized representative in Vietnam responsible for registration and regulatory affairs
MOH Application Submission
Submit medical device marketing authorization application to Drug Administration of Vietnam
Technical Review
Pass MOH technical documentation review, clinical evaluation and quality system assessment