Domestic Health Supplement Declaration Service

Health Supplement refers to products used to supplement the daily diet of humans to maintain, enhance, and improve the functions of the human body, aiming to maintain good health and reduce the risk of diseases. Due to this positive effect, the demand for health supplements is increasing.

However, the current market faces the issue of counterfeit and substandard products. To protect consumers in choosing quality products, the law has issued Decree No. 15/2018, which regulates that health supplements wishing to circulate in the market must undergo product declaration.

Conditions for Health Supplement Declaration

Businesses have appropriate business codes with registered products at the Department of Food Safety.

Documents for the Registration of Domestic Health Supplement Declaration

Documents to be provided by the business to the registration unit:

• Good Manufacturing Practice (GMP) certification for the production facility.
• Product Specification – according to the form provided by the registration unit.
• Product label sample.
• Raw material documentation 
• Manufacturing contracts for Entities employ product process

Documents to be prepared by the registration unit:

• Product declaration document.
• Product testing results from a testing facility meeting ISO 17025 standards (valid for 12 months from the submission date).
• Documentation proving the functionality of the product or the declared functionality of its components.
• Dosage and Recommended Nutrient Intake (RNI) tables.
• Commitment statement regarding the non-violation of copyright for product name, logo, and images.
• Other explanations (if there are official dispatches)

Domestic Health Supplement Declaration Process

• Log in to the Decree 15 website: https://nghidinh15.vfa.gov.vn/
• Submit the application online to the Food Safety Department and pay the state fee.
• Within 21 working days for the initial successful submission on the website and 7 days from receiving modification or supplementation, the competent authority will review the application and notify the result on the system.
• If the application is approved, the business will receive a certificate of product declaration. If not approved, an official dispatch will be issued specifying the required modifications or changes. The business then makes the necessary adjustments and resubmits the documents to the Department (approved files => sign the acceptance certificate).

Issuance time:

2-3 months from the initial submission

Why choose Medgate – a reputable and effective domestic health supplement declaration service provider

Medgate is a specialized and reputable provider of health supplement declaration services. We offer quick and effective services, providing advice and support to businesses throughout the health supplement declaration process and in cases that require post-declaration supplementation.

We provide a variety of registration services, including domestic and imported health supplement declaration, medical device, pharmaceuticals, and cosmetics.

We are committed to providing comprehensive support, helping businesses build and maintain their reputation in the health supplement market through the product declaration process

To receive consultation on dossier services and procedural process for declaring domestic health supplements, please contact Hotline: 098.546.1894