Selling Licence Requirements for Specific Medical Devices in Thailand

Q: Is a separate licence needed to sell medical devices in Thailand?

1. Key takeaways

Yes, but only for specific products. Beyond the establishment licence and the product licence, selling the following specific devices in the Thai market also requires a Selling Licence. The distinction matters because it adds a third, annual obligation on top of the two better-known certificates: the registration certificate and the establishment licence both run for five years, while the Selling Licence is valid for only one year, making it the only one of the three certificate types that must be handled every year. Companies that plan Thai SKUs without screening against the Selling Licence list often discover the obligation late, and the consequence lands not at the import stage but directly at the sales stage, where selling a listed product without the licence constitutes an actionable unlicensed operation.

• A Selling Licence applies to a defined product list. Per the Thai FDA official FAQ, it covers HIV test kits, blood bags, ophthalmic viscosurgical devices, teeth whitening devices, silicone breast implants, injectable hyaluronic acid dermal fillers, a detailed list of dental devices, and positive airway pressure (PAP) devices.
• Validity is one year. Unlike the five-year registration certificate and the five-year establishment licence, it must be renewed annually.
• The logic is sales-side control. Thailand strengthens control of the circulation stage through licensing at the point of sale: not only whether the product can be imported, but who may sell it.
• Selling without the licence is an actionable violation. Device sales in Thailand are subject to licensing management, and selling listed products without the licence is a citable non-compliance.
• Section 27 of the Medical Device Act provides exemptions. The exemptions apply upon submission of a notification, covering defined categories such as government agencies, the Thai Red Cross, medical institutions and practitioners.

2. Legal basis

The applicable product list comes from the Thai FDA official FAQ, item 1.2, and the licence type descriptions under the For Commercial Purpose guidance on the Thai FDA website. The listed products are: HIV test kits; blood bags; ophthalmic viscosurgical devices (OVD); teeth whitening devices; silicone breast implants; injectable hyaluronic acid dermal fillers; dental devices, including dental implants, orthodontic brackets and appliances, orthodontic elastics, orthodontic archwires, orthodontic bands, clear dental aligners, teeth etchant, dental filling materials, dental adhesives and cements (except denture adhesives), impression materials, artificial teeth, and fluoride varnish; and positive airway pressure (PAP) devices. The exemption situations are set out in Section 27 of the Medical Device Act B.E. 2551 (2008), and each requires submission of a notification: manufacture, import or sale by government agencies and the Thai Red Cross for prevention, diagnosis, treatment and rehabilitation purposes; manufacture by medical institutions solely for sterilisation purposes as provided by law; manufacture or sale by medical and public health practitioners for their specific patients (or animals); manufacture or import of quantities needed for personal use, samples, exhibitions, and research, analysis or quality testing; import for a specific patient (or animal); manufacture as export samples; and manufacture or import under rules announced by the Minister upon the Boards recommendation.

The common feature of the singled-out products is higher risk or a higher threshold of use: they involve blood safety (blood bags, HIV test kits), implantation into the body (breast implants, dental implants), injection into the body (HA fillers), entry into the eye (OVD), long-term contact (orthodontic materials, PAP devices), or the risk of abuse (teeth whitening devices).

3. Expert insights

The design intent behind the Selling Licence is worth reading carefully, because it shows how Thailand layers its control system. Registration answers whether a device may exist on the market at all; the establishment licence answers which entity may import it; and the Selling Licence answers who may sell it. Three different questions, three different instruments, three different validity periods. The one-year term is the feature most often underestimated in planning. A five-year certificate enters the compliance calendar once and stays there; a one-year licence enters it every year, and because it sits on the sales side rather than the import side, its absence does not show up as a customs problem that blocks cargo at the port. Instead it surfaces as a sales-stage violation, which means the commercial team can be operating in breach for a whole year without any border signal. That is precisely why the practical advice is to screen every SKU against the Selling Licence list first, before channel planning and pricing work begin, and to treat the annual renewal as a fixed calendar obligation with the same discipline as the five-year renewals, even though its cycle is shorter and its fee profile smaller.

4. Practical recommendations

• Screen SKUs against the Selling Licence list first. At Thai SKU planning time, check every product against the listed categories before doing anything else.
• Add the annual renewal to the compliance calendar. If any product falls on the list, add a Selling Licence annual renewal item; its one-year term makes it easier to miss than the five-year certificates.
• Understand where the consequence lands. A missed Selling Licence is a direct violation at the sales stage, not the import stage, so border-focused monitoring alone will not catch it.
• Treat the three certificates as separate clocks. Registration certificate and establishment licence run five years; the Selling Licence runs one year, and the clocks must be tracked separately.
• Check Section 27 exemptions only with advice. The exemptions cover defined categories and require submission of a notification, so they apply only where the facts genuinely fit a stated situation.
• Confirm the licence type early. Use the Thai FDA For Commercial Purpose guidance to confirm which licence types apply to the product portfolio before filings begin.

5. Verification checklist

• □ Thai FDA official FAQ item 1.2 (Selling Licence product list: HIV test kits, blood bags, OVD, teeth whitening devices, silicone breast implants, HA fillers, dental device details, PAP devices)
• □ Selling Licence validity of one year
• □ Section 27 of the Medical Device Act B.E. 2551 (2008) (exemption situations, notification required)
• □ Thai FDA website For Commercial Purpose licence type descriptions

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