How to Successfully Register Functional Foods in Vietnam in 2025: A Complete Guide

Register functional foods in Vietnam is a mandatory step for businesses looking to import, distribute, or sell health supplements in this fast-growing market. With increasing demand for wellness products, understanding the functional food registration process and complying with Vietnam functional foods regulations is essential. This article provides a comprehensive guide on how to register functional foods, including the legal basis, required documents, and a detailed step-by-step procedure for approval in Vietnam.

Legal Basis for Registering Functional Foods in Vietnam

To register functional foods in Vietnam, businesses must comply with specific legal regulations issued by the Vietnamese government. The current Vietnam functional foods regulations are based on the following key legal documents:

• Law on Food Safety No. 55/2010/QH12, amended and supplemented in 2018: This is the foundational law governing all food-related activities in Vietnam, including the production, import, and sale of functional foods.

• Decree No. 15/2018/ND-CP, detailing the implementation of several articles of the Law on Food Safety, as amended by Decree No. 155/2018/ND-CP: This decree outlines the functional food registration process, including self-declaration procedures, document requirements, and post-market responsibilities.

• Circular No. 67/2021/TT-BTC issued by the Ministry of Finance: This circular regulates the fees, submission process, and financial obligations involved in ensuring food safety—directly impacting the cost and management of functional food approval in Vietnam.

What Are Functional Foods?

According to Clause 23, Article 2 of Vietnam’s Law on Food Safety No. 55/2010/QH12, functional foods are defined as food products that support and enhance the functions of the human body, promote well-being, increase immune resistance, and reduce the risk of diseases. Under Vietnamese law, functional foods include the following main categories:

• Dietary supplements: Products intended to supplement the normal diet with nutrients such as vitamins, minerals, amino acids, or other beneficial substances.

• Health supplements: Products designed to protect health, improve bodily functions, and reduce health risks.

• Medical nutrition foods: Specialized foods formulated for individuals with specific medical or nutritional needs, used under medical supervision.

Understanding these definitions is essential for compliance with Vietnam’s functional food registration regulations and for accurate product classification during the registration process.

What Is Functional Food Registration?

To legally import or sell functional foods in Vietnam, businesses must comply with the country’s strict functional food registration process. Unlike regular foods that may only require self-declaration, functional foods fall under a regulated category that demands official approval through the Functional Food Product Declaration system.

Under Vietnam functional foods regulations, registration is not optional—it is a mandatory legal requirement designed to protect public health and ensure transparency in the marketplace. This procedure is essential for businesses seeking functional food approval in Vietnam and applies to both local and imported products.

According to Article 6 of Decree No. 15/2018/ND-CP, organizations and individuals engaged in the production and trading of functional foods must register product declarations for the following types of functional foods:

Required Documents for Functional Food Product Declaration in Vietnam

To successfully register functional foods in Vietnam, businesses must prepare a complete dossier in accordance with the Vietnam functional foods regulations. The following documents are required as part of the Functional Food Product Declaration process:

1. Functional Food Product Declaration Form

The official registration form must follow Form No. 1 under Decree 15/2018/ND-CP. It must be completed in Vietnamese and signed by the authorized legal representative.

2. Product Information Sheet

A detailed sheet providing comprehensive information about the functional food product, including:

• Product name

• Full list of ingredients and their respective concentrations

• Product use purpose and recommended dosage

• Target users and contraindications

• Storage conditions and shelf life

3. Product Label Samples

Two versions of the label must be submitted:

• The original label (in the product’s native language)

• The Vietnamese-translated label, fully compliant with local labeling regulations for functional foods

4. Certificate of Free Sale (CFS)

For imported functional foods to be eligible for distribution and functional food approval in Vietnam, a Certificate of Free Sale (CFS) is a mandatory document in the registration dossier. The CFS must meet the following conditions:

• Issued by the competent authority in the product’s country of origin.

• Must clearly state that the functional food is legally manufactured and marketed in that country.

• The product name, manufacturer’s name, and address should be accurately listed.

In cases where a CFS is not available, an equivalent document such as an Export Certificate may be submitted, provided it contains similar details and is recognized by Vietnamese authorities.

Important:
To be valid for the Functional Food Product Declaration, the CFS must be legalized by the Vietnamese Consulate or Embassy in the country of issuance. This consular legalization step ensures the document’s authenticity for use in Vietnam’s regulatory system.

5. Product Testing Results

• Microbiological and heavy metal analysis results must be issued within the last 12 months.

• Testing must be performed by a laboratory certified to ISO/IEC 17025.

• Tests confirm the safety of the product for human consumption.

6. Scientific Evidence of Health Benefits

To support any health claims made on the label, businesses must submit:

• Clinical studies, published scientific literature, or trial data

• Documentation must be credible and align with the claimed benefits (e.g., immune support, digestive aid)

7. Good Manufacturing Practice (GMP) Certificate

A valid GMP Certificate issued by the competent authority in the manufacturing country is required. This applies to both local and foreign manufacturers to ensure quality and safety in production.

Step-by-Step Registration Procedure

To ensure compliance with Vietnam functional foods regulations, businesses must follow a strict process known as the Functional Food Product Declaration. Below is a detailed step-by-step guide to completing the functional food registration process in Vietnam:

Step 1: Prepare the Registration Dossier

To begin the process to register functional foods in Vietnam, businesses must prepare a complete dossier in accordance with Decree No. 15/2018/ND-CP. All documents must be translated into Vietnamese. Proper preparation ensures compliance and avoids delays in the registration process.

Step 2: Submit the Functional Food Product Declaration

The Functional Food Product Declaration dossier must be submitted to the relevant competent authority, depending on the product category:

• Health supplements: Submit to the Ministry of Health (Vietnam Food Administration – VFA)

• Medical nutrition foods: Submit to the competent state authority appointed by the provincial People’s Committee

Submission Methods:

• Online via Vietnam’s National Public Service Portal

• By post (official postal service)

• In-person at the authority’s office

Step 3: Dossier Review and Approval by the Competent Authority

Upon receipt, the authority will evaluate the registration dossier within the following timelines:

• 7 working days for medical nutrition foods

• 21 working days for health supplements

These timelines start from the date the dossier is submitted via the online portal or from the date stamped by the receiving agency (if submitted by post or in person).

If the dossier is incomplete or unsatisfactory, the authority will issue an official notice outlining the legal basis for requesting revisions. Notably:

• The authority is allowed to request amendments or additions only once

• After resubmission, the authority has 7 working days to review the updated dossier

• If no revision is submitted within 90 working days, the dossier will be deemed invalid

Step 4: Public Announcement of Product Registration

Once the product receives functional food approval, the competent authority will publish the following on its official website and the national food safety database:

• Name of the registered company or individual

• Approved product name(s)

This announcement formalizes the product’s legal status and authorizes its importation and distribution in Vietnam.

FAQs on Functional Food Registration in Vietnam

1. Is a local entity required for functional food registration in Vietnam?
   Yes. Foreign companies must appoint a local legal entity in Vietnam—such as an importer or representative office—to handle the registration process.

2. What are the consequences of selling functional foods without registration?
   Selling unregistered functional foods in Vietnam is illegal and can lead to severe penalties, including fines, product recalls, or import bans.

3. Do I need to renew my functional food registration declaration?
   The declaration generally does not expire unless there are changes to the product’s composition or labeling. However, Vietnamese authorities may request updated product testing or Good Manufacturing Practice (GMP) certificates periodically.

4. Is it necessary to register every variation of a functional food product?
   Yes. Each product variation—including different flavors, dosage forms, or formulations—must be registered separately with the authorities.

Conclusion

Registering functional foods in Vietnam is a mandatory legal requirement and a vital step to successfully enter the Vietnamese health supplement market. A thorough understanding of the legal framework, meticulous document preparation, and strict adherence to registration procedures are essential to ensure compliance and smooth market access.

For expert assistance with functional food registration in Vietnam, Green NRJ provides comprehensive services—from dossier preparation and product testing coordination to local legal representation.

Contact us today to streamline your functional food registration process and confidently launch your products in Vietnam!