Health Supplements Registration in Vietnam: A 2026 Guide for Foreign Companies

Vietnam's health supplement market continues to attract foreign brands, but businesses entering the market need to understand the registration, labelling, advertising and import requirements that apply to their products.

The regulatory framework changed in early 2026 with the introduction of Decree No. 46/2026/ND-CP and Resolution No. 66.13/2026/NQ-CP. However, both instruments are currently suspended. Decree No. 15/2018/ND-CP and its relevant guiding documents therefore continue to provide the applicable framework for health supplement registration while the amended Law on Food Safety is pending.

For manufacturers, distributors and foreign investors, the practical question is therefore not only how to register a health supplement in Vietnam, but also how to make sure the product, dossier, label, advertising content and import arrangements meet the requirements currently in force.

This guide explains what counts as a health supplement, the current registration rules, the documents involved, the registration process and the key requirements foreign companies should consider before entering the Vietnamese market.

What Counts as a Health Supplement in Vietnam?

In Vietnam, a health supplement is a regulated category of functional food. It is intended to supplement the daily diet with concentrated nutrients or bioactive substances, and is presented in measured dosage forms such as capsules, tablets, powders, liquids or granules.

Health supplements may be presented in dosage forms such as:

• Capsules and softgels
• Tablets
• Granules
• Powders
• Liquids
• Other forms divided into smaller doses

A product generally falls within this category where it contains one or more of the following:

• Nutrients and bioactive substances: Vitamins, minerals, amino acids, fatty acids, enzymes and probiotics.
• Natural-sourced substances: Extracts or concentrates derived from animals, minerals or plants.
• Synthetic equivalents: Synthetic versions of the substances above.

This definition separates health supplements from conventional foods. A capsule or sachet format and words such as "support" or "improve" are indicators worth reviewing, but they are not enough on their own to determine the classification. The ingredients, intended use and presentation of the product should be assessed together, and the classification confirmed before the label, claims and dossier are finalised.

Which Health Supplement Registration Rules Apply in 2026?

Several instruments issued in early 2026 affect health supplements, and they do not all have the same status. The table below summarises the position.

How to Register Health Supplements in Vietnam?

For businesses looking to register health supplements in Vietnam, the current process can be broken down into five stages.

Step 1: Confirm the Product Classification

Before preparing the registration dossier, confirm that the product falls within the health supplement category.

Review the ingredients, dosage form, intended use and proposed claims together. This is important because the product classification determines the registration route and the documents that need to be prepared.

Health supplements are subject to registration of the product declaration rather than the self-declaration route that applies to many ordinary packaged foods.

Step 2: Prepare the Product Registration Dossier

For an imported health supplement, Article 7 of Decree No. 15/2018/ND-CP sets out the core dossier requirements.

These include:

• Product declaration: Prepared using Form No. 02 under Decree No. 15/2018/ND-CP.
• Certificate of Free Sale, Certificate of Exportation or Health Certificate: Issued by the competent authority in the country of origin or exporting country and meeting the applicable requirements.
• Food-safety testing report: Issued no more than 12 months before submission by a designated laboratory or a laboratory accredited to ISO/IEC 17025, as applicable.
• Scientific evidence: Evidence supporting the declared effects of the product or its relevant ingredients.
• GMP certificate or equivalent: Required for imported health supplements.

Documents in a foreign language must be translated into Vietnamese and notarised, and documents must remain valid when the dossier is submitted.

Businesses should also make sure that the product information, label, scientific evidence and proposed claims are consistent before submitting the dossier.

Step 3: Submit the Registration Dossier for Review

For health supplements, the product declaration registration dossier is submitted to the Ministry of Health.

The dossier can be submitted through the online public service system, by post or directly, as provided under Decree No. 15/2018/ND-CP.

For a complete dossier, the statutory review period for a health supplement is 21 working days. If the authority requests amendments or additional information, the process can take longer. The authority may request amendments or supplementation once, with a further review period applying after the amended dossier is submitted.

Step 4: Finalise Labelling and Advertising Requirements

Registration is only one part of preparing a health supplement for the Vietnamese market.

Product labels must comply with the current labelling framework under Decree No. 37/2026/ND-CP, which took effect on 23 January 2026 and replaced the previous labelling rules under Decrees 43/2017 and 111/2021.

Businesses should ensure that the Vietnamese label contains the mandatory information applicable to the product and that the information is consistent with the registered product details.

Advertising must also be considered separately. Health supplement advertising content must be confirmed before release. Under Resolution No. 21/2026/NQ-CP, this responsibility was transferred to the Chairperson of the provincial People's Committee from 1 July 2026. The applicable procedure provides for a 10-working-day review period from receipt of a complete and valid dossier.

Advertising content must comply with Decree No. 342/2025/ND-CP, including the required health supplement wording and the warning that the product is not a medicine and is not a substitute for medicines.

Claims should remain consistent with the registered product information and supporting evidence. Businesses should avoid wording or imagery that suggests the product can diagnose, treat or cure disease.

Step 5: Prepare for Import and Market Circulation

Once the product registration requirements have been completed, businesses should coordinate the registration documentation with their import arrangements.

Under Article 13 of Decree No. 15/2018/ND-CP, imported food that holds a certificate of receipt of its registered product declaration is exempt from state food-safety inspection at import, unless a food-safety warning applies to the product.

This does not replace customs procedures or other applicable import requirements.

Before the first shipment, businesses should make sure that the relevant registration documents and commercial documentation are consistent with the product and its label.

Allowing sufficient time for customs procedures and documentation checks can also help businesses plan their initial shipments more effectively.

What Does a Health Supplement Registration Dossier Cover?

For imported health supplements, the current dossier under Article 7 of Decree No. 15/2018/ND-CP includes the following core documents:

A letter of authorisation may also be relevant depending on the applicant and the arrangement with the manufacturer, but it should not be presented as a separate mandatory item in the basic Article 7 dossier for every application.

Similarly, a stability study can be relevant to product quality and GMP processes, but it should not be presented as a standalone mandatory registration document under Article 7 unless another applicable requirement calls for it.

This distinction is important because the suspended 2026 framework proposed additional requirements that should not be treated as current registration requirements.

What Should Manufacturers Check on Facilities and Production?

GMP is not a new 2026 requirement for health supplement manufacturers. Under Decree No. 15/2018/ND-CP, health supplement manufacturers have been required to apply GMP since 1 July 2019.

Manufacturers should review areas such as:

Technical Expertise

The professional manager of a health supplement manufacturing establishment must have a bachelor's degree or higher in medicine, pharmacy, nutrition, food safety or food technology and at least three years of relevant experience.

Documented GMP System

The facility should maintain documented systems covering production, quality control, distribution and traceability.

Trained Personnel

Employees should receive appropriate GMP, food-safety and job-specific training.

Local Manufacturing Requirements

Where health supplements are manufactured in Vietnam, the facility must meet the applicable food-safety and GMP requirements. Decree No. 15/2018/ND-CP provides a specific procedure for obtaining a certificate of food-safety eligibility under GMP requirements for health supplement production.

Businesses should confirm the facility requirements that apply to their particular manufacturing arrangement before operations begin.

How Do Labelling and Advertising Rules Apply?

Labelling and advertising should be considered alongside product registration rather than treated as separate tasks at the end of the process.

Labelling

Decree No. 37/2026/ND-CP is the current goods labelling framework. It took effect on 23 January 2026 and replaced the previous labelling requirements under Decree Nos. 43/2017/ND-CP and 111/2021/ND-CP.

For imported health supplements, businesses should ensure that the required Vietnamese labelling is in place before the product is circulated in Vietnam and that the information is consistent with the registered product declaration.

Health Claims

Health claims should match the registered product information and be supported by the relevant scientific evidence.

Health supplements must not be presented as medicines or advertised as products that diagnose, treat or cure disease.

Advertising Confirmation

Health supplement advertising requires confirmation before release.

Under Resolution No. 21/2026/NQ-CP, applications are now handled through the provincial-level authority, with the Chairperson of the provincial People's Committee responsible for the confirmation from 1 July 2026. The stated review period is 10 working days from receipt of a complete and valid dossier.

Advertising Content

Decree No. 342/2025/ND-CP sets out the information required in food advertisements, including the product name, responsible organisation or individual, product effects and relevant health warnings. Health supplement advertising must also include the required statement that the product is not a medicine and is not a substitute for medicines.

Businesses should therefore review advertising content before launch rather than assuming that product registration automatically clears the advertising material.

What Should Importers Expect at Customs?

Imported health supplements need to be considered from both a food-safety and customs perspective.

Under the current Decree 15 framework, an imported food product holding a certificate of receipt of its registered product declaration may be exempt from state food-safety inspection at import unless a food-safety warning applies.

Before the First Shipment

Businesses should check that:

• The product declaration registration has been completed.
• The relevant registration documentation is available.
• Import documentation is consistent with the registered product information.
• The product label matches the registered information.
• Commercial documents such as the invoice and packing list are accurate.
• Any applicable food-safety or customs requirements have been addressed.
• Also, you need to allow buffer time in the supply chain, particularly for first shipments

The risk-based inspection system proposed under Decree 46/2026 should not be presented as the current import inspection system because the decree is currently suspended.

What Should Foreign Companies Assess Before Registering?

The registration process is only one part of health supplement market entry in Vietnam. Foreign companies should also consider how the product will be imported, marketed and managed after registration.

Confirm the Product Classification

Review the ingredients, dosage form, intended use and proposed claims before finalising the registration route.

Identify the Registration Holder

Decide who will hold the product registration, who will import the product and who will take responsibility for the relevant compliance obligations.

Align the Product Information

The product declaration, label, scientific evidence and advertising claims should be consistent.

Review the Manufacturing Arrangement

Confirm whether the product will be manufactured overseas or in Vietnam and identify the GMP and facility requirements that apply.

Plan the Advertising Process

If the product will be advertised in Vietnam, include the advertising-content confirmation process in the launch timetable.

Allow for Regulatory Changes

Although Decree 15/2018 currently remains the applicable framework, the food-safety regulatory environment is changing. Businesses should monitor developments and review how future changes may affect existing products and registrations.

How Ascentium Supports Health Supplement Market Entry in Vietnam

Registering a health supplement is one part of entering Vietnam's market. The product classification, registration route, manufacturing arrangement, labelling, advertising, import process and ongoing compliance requirements all need to be considered together.

Ascentium Vietnam can support foreign companies in Vietnam assessing these requirements and coordinating related corporate, accounting, tax and workforce considerations as part of their Vietnam market-entry plans.

Our support can also extend beyond initial setup as businesses establish and develop their local operations.

Conclusion

Health supplement registration in Vietnam requires businesses to address product classification, product declaration registration, documentation, GMP, labelling, advertising and import requirements as part of the same market-entry process.

For now, Decree No. 15/2018/ND-CP and its relevant guiding documents remain the basis for health supplement registration, while Decree No. 46/2026/ND-CP and Resolution No. 66.13/2026/NQ-CP remain suspended.

Foreign companies planning to enter the Vietnamese market should therefore prepare their registration and launch plans around the requirements currently in force, while keeping track of further changes to the food-safety framework.

Frequently Asked Questions