Vietnam Product Registration & Certification
Important Notes
- MOH & DAV Mandatory Circulation License: All pharmaceuticals, medical devices, cosmetics, and functional foods require a Circulation License issued by the Ministry of Health or the Drug Administration.
- Functional Foods as a Statutory Independent Category: Vitamins, mineral supplements, etc., are explicitly defined as Functional Foods requiring registration. Functional claims must be scientifically evaluated and approved.
- 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: Drug and some device prices must be declared. Inclusion in the National Health Insurance Drug List is key for public hospital market share and reimbursement.
- Growing Emphasis on Local Clinical Trial Data: For innovative drugs and high-risk 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 multinationals.
- Accelerated Regulatory Reform & Modernization: The DAV is actively aligning regulations with international standards and optimizing e-registration, though inconsistencies may arise during transition.
- Coexisting Markets of Traditional Herbs & Modern Functional Foods: Herb-based Functional Foods represent a huge and fast-growing segment, alongside modern supplements.
- Public Hospital Dominance with Rapid Private Channel Growth: Public hospitals remain primary treatment and drug dispensing points, but private hospitals, pharmacy chains, and modern trade are growing much faster.
- Active ASEAN Member & Beneficiary of Manufacturing Shift: Vietnam actively participates in ASEAN harmonization and is becoming a key regional manufacturing base for pharmaceuticals and health products due to cost advantages and FTAs.
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 registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, pharmaceuticals, and functional foods. Serves as the supreme health regulatory authority in Vietnam.
DAV
Drug Administration of Vietnam (DAV)
Responsible for specific registration approval, technical review, and post-market surveillance of medical devices and pharmaceuticals
VFA
Vietnam Food Administration (VFA)
Responsible for registration approval, safety regulation, and market supervision of functional foods and general food products
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
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Declaration
- Ingredient Safety Assessment Report (Vietnamese)
- Vietnamese Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Manufacturer Qualification Proof
- Microbiological Test Reports
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Product Declaration Submission
- Labeling Review Preparation
- Market Access Completion
Registration Timeline
4-7 months
Official Fees
VND 15,000,000 - 100,000,000
Service Fees
$9,000 - $22,000
Regulatory System Overview
MOH Vietnam
Ministry of Health Vietnam
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, pharmaceuticals, and functional foods. Serves as the supreme health regulatory authority in Vietnam.
DAV
Drug Administration of Vietnam (DAV)
Responsible for specific registration approval, technical review, and post-market surveillance of medical devices and pharmaceuticals
VFA
Vietnam Food Administration (VFA)
Responsible for registration approval, safety regulation, and market supervision of functional foods and general food products
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Vietnam cosmetic regulations permitted and restricted lists
Safety Assessment Report
Prepare Vietnamese product safety assessment report signed by qualified safety assessor
Product Declaration Submission
Submit cosmetic product declaration and related technical documents to Ministry of Health
Labeling Compliance Review
Ensure product labeling fully complies with Vietnam cosmetic labeling regulations
Manufacturer Registration
Complete manufacturer registration procedures with Vietnam Ministry of Health
Functional Foods Registration
Regulatory Requirements
- Functional Food Declaration
- Ingredient Safety and Quality Standards Proof
- Vietnamese Product Labeling
- Good Manufacturing Practice Certification
- Scientific Basis for Functional Claims
- Nutritional Composition Analysis Report
- Product Efficacy Proof
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- Product Declaration Submission
- Labeling Review Preparation
- Declaration Certificate Acquisition
Registration Timeline
5-9 months
Official Fees
VND 20,000,000 - 200,000,000
Service Fees
$11,000 - $30,000
Regulatory System Overview
MOH Vietnam
Ministry of Health Vietnam
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, pharmaceuticals, and functional foods. Serves as the supreme health regulatory authority in Vietnam.
DAV
Drug Administration of Vietnam (DAV)
Responsible for specific registration approval, technical review, and post-market surveillance of medical devices and pharmaceuticals
VFA
Vietnam Food Administration (VFA)
Responsible for registration approval, safety regulation, and market supervision of functional foods and general food products
Functional Foods Registration Process
Product Classification Confirmation
Confirm product meets Vietnam functional food definition and provide functional claims basis
Technical Documentation Preparation
Prepare Vietnamese technical documents including ingredient analysis, safety evidence, efficacy proof
Product Declaration Submission
Submit functional food declaration application to Vietnam Food Administration
Labeling Review
Ensure labeling complies with Vietnam food labeling regulations and functional claims requirements
Functional Claims Review
Review all functional claims for compliance with Vietnam functional food claims regulations