Most food, supplement and medical-device brands meet the Thai Food and Drug Administration (Thai FDA) at the same moment: the product is ready, the stock is ordered, and someone asks "who is doing the FDA?".
That is late. The Thai FDA approval is not a stamp on the box. It is a licence held by a particular business in Thailand, and whoever holds it controls whether the product can be sold. This guide covers the decisions that should be made before anything is filed.
It sits alongside our guide on cosmetic notification, which covers cosmetics. This one covers food, dietary supplements and medical devices.
1. Find the right route first
Each product type has its own law and its own route. Getting the category wrong is expensive, because every later step builds on it.
| Product | Regulated as | What usually has to be obtained |
|---|---|---|
| General packaged food | Food | Premises licence or registration, plus the product's food serial number where required |
| Dietary supplement | Food (not medicine) | Premises licence, product approval with a food serial number, label review |
| Medical device | Medical device | Establishment licence, then listing, notification or licence depending on risk class |
| Herbal product with health claims | Often a separate herbal-product route | Depends on the formula and the claims |
Two points catch brands out:
- Supplements are food. They cannot be sold with claims to treat, cure or prevent disease. If the sales pitch depends on a medical claim, the product is in the wrong category.
- The same product can fall into different categories depending on its ingredients, dose and claims. A borderline product should be classified before the label is designed.
2. The premises come before the product
The Thai FDA does not approve a product in the abstract. It approves a product made or imported by a licensed business at an inspected place.
- A manufacturer needs its production site licensed or registered, meeting the applicable good manufacturing standard
- An importer needs an import licence and a storage place that the authority can inspect
- A medical device importer or manufacturer needs an establishment licence
Only then is each product filed under that business. The practical consequence: choosing who will be the manufacturer or importer of record is the first decision, not a formality at the end.
3. Who should hold the approval
This is the question most brands skip, and it is the one that costs the most later.
| Holder | Advantages | Risks you accept |
|---|---|---|
| Your own Thai company | You control the approvals and can change factories or distributors | You need a Thai entity, a qualified premises or partner, and people responsible for compliance |
| Thai importer or distributor | Fast start, no Thai entity needed | The approvals are tied to the distributor; changing partner can stop sales |
| OEM manufacturer | The factory handles everything | Tied to one factory; switching manufacturer means refiling |
When a relationship ends, brands often find they still own the formula and the trademark but cannot sell their own product in Thailand until it is filed again under a new holder.
If a partner must hold the approvals at the start, the contract should say:
- The approvals are held for the brand's benefit
- The holder must cooperate in transferring or cancelling them when the contract ends
- Product documents, test reports and formula information stay with the brand
- A penalty heavy enough to make cooperation the easier option
The same decision appears in whether to sell through a distributor or your own entity, and should be made together with it.
4. Imported products: documents from the origin country
For imported food, supplements and devices, the Thai filing relies on documents from the manufacturer abroad. Typical requests include:
- A certificate of free sale or equivalent showing the product is lawfully sold in the origin country
- A manufacturing standard certificate for the factory
- The formula or specification, with ingredient details
- Test reports from an acceptable laboratory
- For devices, technical files proportionate to the risk class
Many of these must be legalised or translated. Ask the foreign manufacturer for them early, and put the obligation to provide them in the supply contract.
5. Labels: Thai language and no stretched claims
Labels are where approvals are most often questioned after launch.
- Required information must appear in Thai
- The label must match what was approved — name, ingredients, claims
- Claims about health effects must stay within what the category allows
- Before-and-after images and "cures" language are high-risk for any food or supplement
Check the brand name at the same time. If the name conflicts with an existing trademark, the whole print run may have to be discarded. See registering a trademark in Thailand.
6. Advertising needs its own approval
For food, including supplements, advertising that describes quality, properties or benefits generally needs prior approval from the Thai FDA. The approved wording then sets the limits for:
- Your website and marketplace listings
- Social media posts and live selling
- Influencers and affiliates promoting the product
Liability for unlawful advertising can reach the advertiser and those who publish it, not only the product holder. Give influencers a written script based on the approved wording, and keep control of it in the contract.
Medical devices have their own advertising rules. Claims must match the approved intended use.
7. Liability when a customer is harmed
Holding the approval does not mean the product is safe in law's eyes. If a product causes harm, Thailand's product liability law can reach:
- The manufacturer and importer
- The seller, where the manufacturer or importer cannot be identified
- A brand owner who puts their name or trademark on the product in a way that presents them as the manufacturer
The injured person does not need to prove negligence. A clause making the factory "solely responsible" does not stop a consumer claiming against the brand, but it does give the brand a right of recourse. Pair it with product liability insurance.
Before you file
- Classify the product: food, supplement, device, or something else
- Decide who will be the manufacturer or importer of record, and who holds the approvals
- Put the holder's duties and exit obligations in writing
- Collect origin-country documents and test reports
- Check the brand name against existing trademarks
- Draft the Thai label and marketing wording within the category's limits
- Plan the advertising approval before the launch campaign
Read next
- Cosmetic notification: who should be the holder
- Registering a trademark in Thailand
- Selling into Thailand: distributor or your own entity
- Mandatory product standards and liability
- To plan the holder, contracts and filing route before you launch, talk to our team
