Borderline Products: Device, Drug, Cosmetic or Food in Thailand

Borderline products are where Thai classification decisions most often go wrong. This page sets out how drug-device combination products are allocated between regimes, which cosmetic-looking products are actually devices, how foods, disinfection products and software are treated, what to do when classification is uncertain, and why marketing claims are the decisive factor throughout.

1. Key takeaways

Drug-device combination products are allocated by intended use and principal mechanism of action. Products whose principal intended action is pharmacological, immunological or metabolic are regulated as drugs, handled by the drug division of the Thai FDA; products whose principal intended action is not pharmacological, immunological or metabolic are regulated as medical devices. The judgment is based on the intended purpose and use reflected in the labelling, instructions for use and accompanying documents provided by the product owner. The same claims-driven logic governs cosmetics, foods, disinfection products and software, and where classification is uncertain, the Thai FDA offers a product identification and classification confirmation route.

• Combination products. Allocated by intended use and principal mechanism of action, judged from the labelling, manual and accompanying documents provided by the product owner.
• Cosmetic-looking devices. Thailand explicitly lists certain products as devices requiring a sales licence, including teeth whitening devices, injectable hyaluronic acid dermal fillers, and silicone breast implants.
• Foods and supplements. Products intended for eating or nutritional supplementation fall to the food regime, handled by the food division of the Thai FDA, unless claims of diagnosis, treatment or prevention push the product into the device or drug framework.
• Software. Software with a medical intended purpose is regulated as a device and classified by intended use. Unlike Vietnam, Thailand has no exclusion clause for software used with medical devices.
• Uncertainty route. Submit a product identification application or a classification confirmation application to the Thai FDA.

2. Legal basis

The starting point is the definition of a medical device in Section 4 of the Medical Device Act B.E. 2551 (2008). The Thai FDA website FAQ provides a product identification application channel, and its definitions page supports the same analysis. The Thai FDA list of products subject to a sales licence explicitly includes teeth whitening devices, injectable HA dermal fillers and silicone breast implants, demonstrating that these products belong to the device regime rather than the cosmetics regime. The MoPH risk classification notification B.E. 2562 (2019) supplies the risk classification dimensions that apply to software, which is classified by its intended use. The Thai FDA website commercial purpose process, at Step 7, requires that advertising content be consistent with the approved intended use, which connects classification conclusions directly to marketing compliance. The judgment criterion across all borderline questions is whether the product claims a medical intended purpose, namely diagnosis, treatment, alleviation, replacement or modification of the structure of the body; claims of cleaning, beautification or change of appearance may place a product in the cosmetics regime, while claims involving a medical purpose or injection or implantation into the human body place it in the device regime.

3. Expert insights

The high-frequency misjudgement in Thailand involves products that look like cosmetics but are legally devices. The Thai list of products requiring a sales licence names teeth whitening devices, injectable hyaluronic acid dermal fillers and silicone breast implants, and each of these is marketed to consumers in appearance-driven categories. The dividing line is the claim: if the claim is cleaning, beautification or change of appearance, the product may fall to cosmetics; if the claim involves a medical purpose or injection or implantation into the body, it is a device. Claims are the key to the dividing line throughout, including for foods and supplements, where any claim of diagnosing, treating or preventing disease may bring the product into the device or drug framework.

Disinfection products are judged by use: general disinfection products for humans or the environment are assessed against the device definition by their use, and where the intended use relates to the disinfection of devices and constitutes a medical use, the product may fall to the device regime. The judgment basis is the intended use claim, and it cannot be inferred from the form of the product or its sales channel.

Software deserves a cross-border caution. Software with a medical intended purpose is regulated as a device in Thailand and classified by intended use. This differs from Vietnam, where Decree 98, Article 3.8, excludes software used with medical devices from the classification and circulation number procedures. Thailand has no such exclusion clause, and companies planning multi-country rollouts should not apply Vietnamese rules to Thailand.

4. Practical recommendations

• Do not settle borderline questions by internal discussion alone. Follow three steps.
• First, make a written determination under the device definition and the classification rules, and keep the determination on file with its rule-based reasoning.
• Second, where a determination cannot be made internally, apply for classification confirmation or product identification through the licence holder to the Thai FDA. The judgment basis requires the manufacturer or product owner to provide the labelling, instructions and accompanying documents. This route costs far less than discovering a misclassification after submission.
• Third, once the conclusion is obtained, check in parallel whether the claims used in marketing materials are consistent with that conclusion. This third step is the most easily overlooked, yet it is the main source of advertising violations: a product registered as a device but promoted with cosmetic-style language produces content inconsistent with the registered scope.
• Re-run the three steps whenever a claim changes, since a new claim can move a product across the border line and invalidate a previously correct classification.

5. Verification checklist

• □ Confirm Section 4 of the Medical Device Act B.E. 2551 (2008): the definition of a medical device.
• □ Confirm the Thai FDA website FAQ third question on the product identification application channel, together with the definitions page.
• □ Confirm the Thai FDA list of products subject to a sales licence, including teeth whitening devices, HA dermal fillers and silicone breast implants.
• □ Confirm the MoPH classification notification B.E. 2562 (2019) on the risk classification dimensions for software.
• □ Confirm the Thai FDA website process under For Commercial Purpose, Step 7: advertising content must be consistent with the approved intended use.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com