Who Needs Vietnam FDA Registration?
If any of your products or offered services fall under the categories below, you must secure the proper licenses.
Food and Beverages
Includes food, supplements, bottled drinks, and imported food items. Requires product registration with the Ministry of Health (MOH) and valid business registration for food importation or distribution.
Drugs and Pharmaceuticals
Covers prescription medicines, over-the-counter drugs, vaccines, and traditional medicines. Requires product registration with the Drug Administration of Vietnam (DAV) and an import license. Only licensed pharmaceutical companies can distribute.
Cosmetic Products
Applies to skincare, makeup, haircare, and personal hygiene items. Requires a cosmetic product notification submitted to the MOH and a registered entity authorized to import and distribute cosmetics in Vietnam.
Medical Devices
Covers diagnostic equipment, surgical tools, hospital supplies, and home-use medical devices. Requires classification (Class A to D), product registration with the MOH, and import rights under the company’s business license.
Types of FDA Certificates in Vietnam
Vietnam requires different certificates depending on the type of product you’re registering. Here’s a quick overview of the key certificates you may need.
Certificate of Product Self-Declaration
Required for low-risk, pre-packaged food and beverage products. This certificate confirms that the importer has declared the product’s safety and compliance with Vietnam’s food regulations.
Certificate of Registered Declaration (Product Declaration Certificate)
Mandatory for health supplements, functional foods, and fortified food products. Issued after dossier review and local lab testing.
Cosmetic Product Notification Receipt
All cosmetics must be notified to the Drug Administration of Vietnam. Once approved, you’ll receive a notification receipt that allows legal import and sale of the cosmetic product in Vietnam for up to 5 years.
Medical Device Registration Number
Required for Class B, C, and D medical devices. After classification and approval by the Ministry of Health, a registration number is issued, allowing the product to be imported and sold in Vietnam. Class A devices only require a declaration.
Marketing Authorization (MA) Certificate
The official approval for pharmaceutical products, including over-the-counter and prescription drugs. Issued by the Drug Administration of Vietnam, confirming the product meets safety, efficacy, and quality standards.
Import License (for controlled products)
Certain controlled products (drugs, supplements, or specialized devices) require an additional import license. This is granted on a case-by-case basis by the Ministry of Health and may apply even after product registration.
Requirements for a Product Holder in Vietnam
Before registering your product with the FDA Vietnam, you’ll need a local product holder. This must be a Vietnam-registered company that is permitted to import and distribute your product category.
A. Register a Company
Set up a local entity to act as your product registration holder. Your company must have the correct business lines and meet specific documentation and compliance requirements depending on your product type.
B. Use Emerhub as Your Product Holder
Emerhub can act as your authorized local representative in Vietnam, handling product registration, submissions, and compliance without the need to establish your own entity.
C. Appoint a Local Exclusive Distributor
You can assign a Vietnamese distributor to register and import your products. This option is simple but limits flexibility, as your product registration will be tied to one distributor.
Not sure what’s the best choice for your company? Schedule a call to discuss it with one of our consultants.
FDA Registration Process with Emerhub
1
Product Assessment and Classification
Our team will evaluate your product type to make sure it falls under the correct classifications and registration pipeline, as sectioned under Vietnam’s regulations. Vietnam’s product classification includes food, cosmetics, medical devices, and pharmaceuticals.
2
Document Collection and Label Review
We will prepare, translate, and submit the mandatory documents to the authorized local governing unit of your product classification for review. These documents include your product labels, product’s technical aspects, lab reports, and Certificate of Sale (CFS). We’ll also make sure your product’s packaging meets Vietnam’s labeling standards.
3
Local Testing for Applicable Products
For applicable products like health supplements and food, we’ll coordinate with certified local laboratories to conduct thorough tests in accordance with Vietnam’s food product submission requirements.
4
Registration Submission and Follow Up
We will handle the process of preparing and submitting your application to the relevant authorities in charge (MOH, DAV, VFA, MARD, or MOIT), managing all communications, amendments, and updates on your behalf.
5
Approval and Post-Registration Support
Once your product is approved, we will provide you with the official certification that allows you to legally import and sell your product in Vietnam. This could be one of the following:
- Certificate of Product Declaration: For food and beverage products under self-declaration.
- Certificate of Registered Declaration: For health supplements and functional foods.
- Cosmetic Product Notification Receipt: For cosmetic products.
- Marketing Authorization Certificate (MA): For pharmaceuticals.
- Registration Number for Medical Devices: Issued upon approval of device registration (Class B to D).
We will also continue to support you with future renewals, regulatory updates, and any changes to your product post-registration.
Have questions or need more information?
Your Trusted Partner for Vietnam FDA Compliance
With Emerhub, you gain a partner to support you every step of the way with your tax and accounting needs.
14 Years of Local Expertise
With deep expertise in Vietnam’s product registration system, we deliver accurate and practical guidance tailored to local regulations.
On-the-Ground Support
Our Vietnam-based team ensures smooth communication with local authorities and prevents delays due to language and procedural gaps.
Trusted Professional Network
We work with accredited labs, translators, and compliance officers to manage every aspect of your product registration.
FAQs on FDA Registration in Vietnam
It refers to registering a product with the appropriate government authority (MOH, MOIT, MARD, etc.) to legally import, distribute, or sell regulated goods like food, cosmetics, and medical devices in Vietnam.
Any company or individual intending to import and distribute regulated products in Vietnam must go through the appropriate product registration process with the local authority in charge.
Self-Declaration is for low-risk food like prepackaged and processed food, while Registered Declaration is for high-risk items like dietary supplements, functional food, and food for special use. These require formal registration and approval from the Ministry of Health before being sold.
Medical devices in Vietnam are classified into four classes:
- Class A: Low Risk
- Class B: Low to moderate risk
- Class C: Moderate to high risk
- Class D: High risk
Registration is required for all classes, but the process and documentation differ depending on the risk class.
For certain products like health supplements and medical devices, both a product registration license and a separate import license are required to legally import and distribute the products in Vietnam.
Significant changes will require amendments to be made to the application or re-registration, meaning you will have to restart the process. This includes changes in the formula, manufacturer, and labeling.
The Latest in Vietnam’s FDA Registration Regulations
-
Guide to Food Product Registration in Vietnam
Get a comprehensive overview of food product registration in Vietnam. Stay informed about the…
-
Guide to Secure an Import License in Vietnam
Learn how to import goods into Vietnam with an import license. This comprehensive guide…
-
Complete Guide to Cosmetic Product Registration in Vietnam
Overview of cosmetic product registration in Vietnam and key factors to consider for importing…
Schedule a call with an Emerhub consultant in Vietnam
Ready to bring your product into Vietnam? Let us take care of the FDA registration process for you.
Email Us
vietnam@emerhub.com
Call Us
+84 911 413 595
Visit Us
1bis Phạm Ngọc Thạch, Bến Nghé, Quận 1, Hồ Chí Minh, Vietnam