Dietary Supplements Registration

Wiselink Group

Dietary Supplements Registration in Thailand

Thai FDA registration for dietary supplement products with or without License holding
Local Unit Not Required

Register Dietary Supplement Products in Thailand and Let Us Hold Your License
We Handle Everything While You Focus on Sales

With its internal Regulatory Department, Wiselink Group provides comprehensive Dietary Supplements registration services with the Thai FDA. We offer additional value by serving as your license holder, importer, and storage provider if you have not yet registered your Thai Company or if this is not part of your business plan.
Dietary supplement products registration with the Thai FDA requires extensive expertise. Simple file preparation and submission to the Authority are often insufficient and may result in product rejection. Our expertise allows us to guide you through the process and optimize your product documentation for full compliance.
We ensure efficient registration processes across all Thai FDA regulated sectors: Medical Devices, Dietary Supplements, Hazardous Substances, Cosmetics, Food and Drugs.

Wiselink Group services

Professional Registration Services for Complex Cases
Expertise in Challenging Registration Scenarios

Import License

First step for the Dietary Supplement Registration in Thai FDA is the warehouse license, also known as import license. This is the first step that only a Thai Company with defined requirements can complete (including having a warehouse compliant with regulations). The warehouse may be subject to verifications and controls by the post-market Department of Thai FDA.

Manufacturer Accreditation

After the Thai license holder has been authorized for the import, Dietary supplement registration process starts. First step is the Manufacturer's accreditation in Thai FDA system. The factory must provide a valid certificate of quality standard (ISO 22000, HACCP, GMP) issued by an accredited certification body and duly notarized and apostilled by local Authority and by the Thai embassy or consulate at the origin.

Product Registration

Once the manufacturer has been approved, it's time to register the Dietary Supplement Products. Procedure varies according to product's nature: liquid, powder, capsule or compressed forms. In all cases a detailed formula with TDS of all the ingredients must be provided. Standards must respect the Thai FDA requirements, including laboratory analysis of finished product.

OUR STANDARD PROPOSAL FOR DIETARY SUPPLEMENTS REGISTRATION

Wiselink Group registers your Dietary Supplement Products in Thailand under its own license. Your company will be indicated as Manufacturer (see list of relevant certifications that are accepted), and Siam Trade will be indicated as Importer and will use its venue as registered business address in Thai FDA for the Import License issuance.
After warehouse accreditation has been concluded, products will be registered and labels will be created and sent electronically to the manufacturer for application on the external packaging before shipment.
After import procedure has been completed, the product will be stored and delivered to end users (in case of e-commerce) or transferred to the distributor (in case of Business-to-Business) or handled directly by Siam Trade Development in case of Multi Level Marketing projects.
A full process of Dietary Supplements Registration takes from 2 to 4 months. The sole registration of Dietary Supplement takes 3 to 4 weeks.

GENERAL GUIDELINES FOR DIETARY SUPPLEMENT PRODUCTS REGISTRATION IN THAILAND

IMPORTANT UPDATE (APRIL 27, 2021)

FROM OCTOBER 7, 2021 ISO 9001 CERTIFICATION FOR THE MANUFACTURER SHALL NOT BE ACCEPTED ANYMORE. READ THIS ARTICLE TO KNOW MORE: ISO 9001 certification for food supplements registration

Before starting the registration process of a food supplement, the Thai FDA must first approve all ingredients of the product. It is common that an ingredient registered and normally used in other countries may not be among the authorized ingredients in Thai FDA. For new ingredients, the FDA will request additional supporting documents and an external procedure that makes the process longer and more expensive (Novel Ingredient). Before making any decision and before negotiating the cost with the consultant, the Company needs to make strategic decisions about whether to retain the new food ingredient in a formula. The new ingredient can provide a commercial advantage for the product over competitors, but on the other hand the project will have extra costs.

The Applicant must provide (1) the ingredient list for its products; (2) the source of the ingredients; (3) the manufacturing process; (4) the objectives of use; and (5) the targeted consumer group.

Thai FDA requires the following data and information for food supplement registration:

The product label must show the following information for consumers:

Thai FDA requirements for Dietary Supplements Registration

A food supplement can contain common herbal ingredients and other bioactive ingredients at a daily intake level recognized by the Thai FDA. For common vitamin and mineral supplements, the levels of the nutrients must be kept between 15–100% of the Thai Recommended Daily Intake (RDI) to be classified as food supplements.

Food supplements can bear exclusively claims that are in line with the Codex Alimentarius nutrition labelling guidelines. For claims pertaining to functions of nutrients, there is a list of claims that Thai FDA authorizes. They follow this list extremely strictly, and a single word not in compliance may result in rejection.

Thai FDA is in the process of reviewing its regulatory framework for evaluating the substantiation of health claims in harmony with the new ASEAN directives. Food supplements cannot make any medicinal claims, unless the product is a traditional medicine or drug. This represents a significant regulatory consideration.

Health supplements containing ingredients not approved as food ingredients and/or containing vitamins and minerals that exceed the Thai RDI value must be registered as traditional medicines, drugs or any other related sub-categories, such as modern herbal drugs, generic drugs or new drugs.

The full process of Dietary Supplement Registration in Wiselink Group takes 1 to 4 months depending on the completeness of your documentation. The license to import Food supplements is valid for 3 years.

Should you need an approved warehouse for Dietary Supplement or Food Import License Purpose, please see this article with our offer of warehouse units: https://www.siamdevelopment.com/warehouse-for-thai-fda-license/