Product Registration in Vietnam
Register and Start Selling Your Products in Vietnam
Our on-the-ground experts navigate the compliance process for the DAV, VFA, IMDA, and MOH, ensuring your products are registered correctly and efficiently.
A Full-Service Solution for Every Product Category
Our teams have specialized expertise for every major regulatory body in Vietnam. We can help your secure necessary licenses and permits so you can start selling your products in the country.
VFA Registration (Food & Beverages)
Food products in Vietnam fall under the joint oversight of the Ministry of Health (MOH), the Ministry of Agriculture and Rural Development (MARD), and the Ministry of Industry and Trade (MOIT). We identify the right authority for your product, prepare the required dossier, and manage all submissions and follow-ups.
Products that Require Registration
- Packaged and processed foods
- Health supplements and functional foods
- Imported food products
- Bottled beverages and fortified food products
Cosmetic Notification
Cosmetics follow a notification process managed by the Drug Administration of Vietnam (DAV) under the MOH. Notification is conducted on a formula basis, meaning each SKU, shade, or scent requires its own submission.
Products that Require Cosmetic Notification
- Skincare and personal care products
- Makeup and color cosmetics
- Haircare products
- Fragrances Personal hygiene items
Pharmaceutical Registration
All prescription drugs, OTC drugs, vaccines, and traditional medicines must be registered with the Drug Administration of Vietnam (DAV) before they can be imported or distributed.
Products that Require DAV Registration
- Prescription drugs
- Health supplements
- Over-the-counter (OTC) drugs
- Vaccines and biological products
- Traditional and herbal medicines
Medical Device Registration
Medical devices in Vietnam are regulated under Decree No. 98/2021 and overseen by the Infrastructure and Medical Device Administration (IMDA), under the MOH. Vietnam follows the ASEAN Medical Device Directive (AMDD), classifying devices into four risk classes.
Medical Device Classification
- Class A: Bandages, non-invasive exam lights, hospital beds, or simple surgical instruments
- Class B: Surgical gloves, certain catheters, or basic diagnostic tools.
- Class C: Contact lenses, hemodialysis machines, ventilators, and many IVD reagents.
- Class D: Anything that stays in the body (implants), heart valves, or devices that interact with the central nervous system.
Key Regulatory Agencies in Vietnam for Product Registration
These government bodies ensure that food, drug, and consumer products in Vietnam comply with safety, quality, and halal requirements before they are marketed or imported.
Ministry of Health (MoH / Bộ Y Tế)
The overarching authority that sets health regulations and policies for food, pharmaceuticals, cosmetics, and medical devices. All major product registration pathways ultimately sit within or are coordinated by the MOH.
Drug Administration of Vietnam (DAV / Cục Quản lý Dược)
A specialized body under the MOH responsible for processing pharmaceutical and cosmetic registrations. The DAV issues marketing authorization for prescription and OTC drugs, manages the cosmetic notification system, and conducts post-market surveillance.
Ministry of Health (MOH / Bộ Y Tế)
Oversees public health policies that may impact product safety standards, especially for pharmaceuticals, medical devices, and health supplements. It works in conjunction with BPOM in regulating health-related products
Vietnam Food Administration (VFA / Cục An toàn thực phẩm)
The primary authority for food safety and approval of health supplements and functional foods. The VFA issues Certificates of Registered Declaration following dossier review and local lab testing.
Infrastructure and Medical Device Administration (IMDA / Cục Hạ tầng và Thiết bị Y tế)
Formerly the DMEC, the IMDA was restructured under the MOH in January 2025. It oversees the registration of all medical devices from Class A to Class D. Class A and B applications are handled at the provincial Department of Health level. Class C and D applications go through the IMDA centrally.
Ministry of Agriculture and Rural Development (MARD / Bộ Nông nghiệp và Phát triển Nông thôn)
Governs the registration and import of fresh agricultural produce, plant-based food products, and related imports. Relevant for businesses importing fresh fruit, vegetables, or raw plant-based goods for distribution in Vietnam.
Register your Products with Emerhub
We cut bureaucratic delays, providing the necessary legal structure and local expertise to successfully register and distribute your products in Vietnam.
End-to-End Management
We handle classification, dossier compilation, translation, online submission, and follow-up with all government agencies.
Local Entity Solutions
We can incorporate your company or act as your Importer of Record (IOR) for immediate market testing, providing the necessary legal pathway.
MoH Support
Expert guidance on Medical Device classification (A-D), technical dossier preparation, and serving as the required Local Authorized Representative (LAR) when necessary.
Ongoing Compliance
Assistance with mandatory warehouse audits, ensuring packaging and labeling compliance, and timely management of all license renewal processes.
FAQs About Product Registration. in Vietnam
Vietnamese law requires that the license holder (MAH) must be a locally established entity in Vietnam. You can either incorporate your own company (LLC) or use Emerhub as your Local Authorized Representative or Importer of Record (IOR) to hold the licenses on your behalf.
Timelines vary significantly based on product category and risk. Here are some examples:
- Medical Devices (MoH): High-risk devices (Class C/D) often require 6–12 months for technical evaluation and circulation license issuance.
- Cosmetic Notification (DAV): Typically takes 15–30 business days from the date of submission, provided the dossier is complete.
- Food & Supplements (VFA): Standard processed foods (self-declaration) take ~1 week, while health supplements require 1–3 months for formal registration.
Rejection occurs due to incomplete documentation, technical non-compliance, or improper labeling claims. The agency issues an official notice detailing the deficiencies. Emerhub manages this remediation process, analyzing the rejection reasons, updating the dossier, and promptly resubmitting the corrected application.
Vietnam offers expedited product registration pathways for certain product categories.
- Pharmaceuticals and medical devices that have already received approval from a Reference Country (the US, EU, Japan, Canada, or Australia) may qualify for expedited review.
- For Class C and D medical devices, the fast-track pathway can reduce timelines to 2–4 months compared to the standard 10–12 month process.
You will need a local distribution structure, for most regulated categories. This includes a licensed importer and appropriate storage arrangements that meet regulatory standards. Emerhub can support you with local import and distribution services.
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vietnam@emerhub.com
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+84 911 413 595
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