Health Supplement Declaration Registration Service

According to legal regulations, Health Supplements intending to circulate in the market must undergo declaration registration with the Food Safety Administration. Many enterprises aiming to distribute domestically manufactured and imported health supplements in the Vietnamese market may be uncertain How to build a dossier to submit to the competent authority correctly and meet legal regulations.
To address this issue, Medgate with its professional and experienced personnel team, has assisted hundreds of enterprises in completing the declaration registration dossier for Health Supplements.
We commit to providing effective support to help enterprises quickly complete the declaration registration dossier to promptly bring products to market on schedule as committed.

Declaration of domestic or imported  health supplements is a mandatory procedure for enterprises wishing to do business products in the market. All types of health supplements intending to circulate in the Vietnamese market must be granted a declaration registration certificate by the competent authority.

Why is it necessary to make the Registration Declaration Dossier for Health Supplement and Considerations?

For Health Supplements to be manufactured, imported, and circulated in the Vietnamese market, it is mandatory for enterprises to proceed with the declaration registration for the product on the food safety administration’s public service system. Registering the declaration for Health supplement is considered a commitment to the quality and safety of the product with consumer health.

* Considerations:

Enterprises must have a business sector code compatible with the product being registered for declaration on the food safety administration’s public service system (wholesale, retail of food).
The ingredients in the registration declaration dossier must not contain toxic substances according to Circular 42/2017/TT-BYT and Circular 10/2021/TT-BYT.
Medgate’s registration Services:

  • Declaration Registration for Domestic Health Supplements
  • Declaration Registration for Imported Health Supplements
  • Amendments and Supplements after Health Supplements Declaration
  • Advertising Registration for Health Supplements

Call us now for consultation at 098.546.1894 or email us at medgatevn@gmail.com

Documents Required from Customers for Registration:

* For Domestic Health Supplements:

  • Certificate of Good Manufacturing Practice (GMP)
  • Product Specification (SPEC)
  • Product label samples
  • Business registration of the enterprise
  • Product ingredient dossier (for imported ingredients)

* For Imported Health Supplements:

  • Certificate of Free Sale (CFS) – Needs consular legalization
  • Certificate of Good Manufacturing Practice (GMP)
  • Product label samples
  • Product Specification (SPEC)

When preparing the dossier, it is important to note the following:

– The Certificate of Free Sale (CFS) must be consular legalized or may be substituted with certain documents like EC/HC.
– GMP should be valid at the time of registration.
– For the product specification:

  • List ingredients in descending order of weight.
  • Include scientific or Latin names for herbal ingredients.
  • For vitamins, clearly specify the form of use according to Circular 44/2015/TT-BYT, with a daily dosage not exceeding the maximum allowable level.
  • Declare the additive group (eg: Anticaking agent: Talc, etc.). Colorings, flavors and sweeteners must clearly identify whether they are natural, nature-like, synthetic or artificial.
Health supplement declaration consulting service

Health supplement declaration consulting service

Workflow at Medgate, Registration Sequence, Timeframe for Obtaining Results

Workflow at Medgate:

  • Consultation on procedures, documentation for Enterprises to proceed with product declaration registration before manufacturing and business.
  • Consultation on the functions, target subjects according to current regulations of the Food Safety Administration, advisory on requirements, testing criteria, contacting testing units for customers.
  • Preparation of the product declaration dossier.
  • On behalf of the Enterprise to submit the dossier and receive the declaration registration number for the product.

Implementation Sequence:

  • Log in to Decree 15 website: https://nghidinh15.vfa.gov.vn/
    (Before logging in, check if a business sector code is compatible with the product being registered for declaration).
  • Submit the dossier online to the food safety administration + pay the state fee.
  • Within 21 working days for successful first-time submissions on the website and 07 days from receiving amended or supplemented official dispatch. The competent agency will review the dossier and notify the assessment results on the system.
  • In case the dossier is approved, the registration certificate for product declaration will be signed for the enterprise. In case of disapproval, a dispatch will be issued, specifying the issues, errors need amending. Upon receiving the dispatch, the Enterprise will proceed with the amendments, supplements, and resubmit to the Food Safety Administration (approved dossier => sign the declaration registration certificate).

Why Choose Medgate?

  • Professional and experienced personnel team: Medgate’s experts provide consultation on the functions and target subjects of the product according to current regulations, as well as advice on product formula components based on market trends.
  • Time-saving, early registration result return: Experienced specialists in preparing and processing dossiers minimize errors in the product declaration registration process, reducing the need for multiple dossier revisions.
  • Competitive costs in the market.
  • Medgate offers a variety of services: Providing services for advertising registration for products, product label design services, services to do sales websites for customers’ products.
  • Declaration dossier Consultation for customers.
  • Quick turnaround time: 2-4 months from when customers provide all necessary documents for registration.

Customers with inquiries can contact the hotline: 098.546.1894 or email: medgatevn@gmail.com for consultation regarding dossier services, procedural processes, registration declaration pricing, and advertising for Health Supplements.