HEALTH SUPPLEMENT DECLARATION REGISTRATION SERVICE 

Nowadays, People increasingly concerned about health issues and the demand for health supplement use is on the rise. To ensure the protection of consumers in choosing and using high-quality Health Supplement, Vietnamese law stipulates that all Dietary Supplements intended for production and importation for circulation in the market must undergo declaration registration with the Food Safety Department. The registration process is outlined in Decree 15/2018/ND-CP.

Legal basis

• Decree 15/2018/ND-CP issued on February 2, 2018: Provides detailed regulations for the implementation of certain provisions of the food safety law.
• Circular 17/2023/TT-BYT issued on September 25, 2023: Amendments, supplements, and abolishment of some legal documents related to food safety by the Minister of Health.
• Circular 24/2019/TT-BYT issued on August 30, 2019: Regulations on the management and use of food additives.
• Circular 43/2014/TT-BYT issued on November 24, 2014: Regulations on the management of functional foods.
• Circular 44/2015/TT-BYT issued on November 30, 2015: Issued the “List of nutritional substances for use in food.”

Declaration Documents for Dietary Supplement:

For Domestic Products

1. Product declaration
2. Good Manufacturing Practice (GMP) certificate of the facility meeting the requirements of Good Manufacturing Practice for food production
3. Test results of the product according according to  food safety regulations (valid for 12 months)
4. Documentation proving the product’s function or the function of its declared components
5. Dosage calculation table, Recommended Nutrient Intake (RNI) table
6. Product Specification (SPEC)
7. Product label sample

For Imported Products

1. Product declaration
2. GMP certificate of the facility meeting the requirements of Good Manufacturing Practice for food production
3. Test results of the product (valid for 12 months)
4. Certificate of Free Sale (CFS) – Requires consular legalization
5. Documentation proving the product’s function or the function of its declared components
6. Dosage calculation table, Recommended Nutrient Intake (RNI) table
7. Product Specification (SPEC)
8. Product label sample
9. Content for supplementary labels

Procedure for registering product declaration

Medgate Provides Health Supplement Declaration Registration Service

Medgate – Provider of Domestic and Imported Health Supplement Announcement Services

– Consulting on procedures and documentation for businesses to announce their products before manufacturing and trading.

– Providing advice on product functions, target audience according to the current regulations of the Drug Administration of Vietnam, advising on testing requirements, and contacting testing units for customers.

– Compiling documents for the announcement of Health Supplement.

– On behalf of businesses to submit documents and receive the declaration registration certificate for circulation in the market.

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.