FAQs: Medical Devices

1.      When you need to apply the medical device licenses or registration?

If you intend to engage in commercial activities related to medical devices in Thailand, in accordance with the following criteria, you are required to obtain the appropriate licenses, which include:

       1.1   Manufacturing or importing medical devices requires both an Establishment License and Product License.

       1.2   Selling medical devices in the Thai market requires a Selling License for certain specific products, including:

              -          HIV Test Kits

              -          Blood Bag

              -          Ophthalmic Viscosurgical Device (OVD)

              -          Teeth whitening devices

              -          Silicone breast implants

              -          Injectable hyaluronic acid dermal filler.

              -          Dental medical devices including

          o   Dental implants

          o   Orthodontic brackets or braces

          o   Orthodontic elastics

          o   Orthodontic wires

          o   Orthodontic bands

          o   Clear dental aligners

          o   Dental etching

          o   Dental filling materials

          o   Dental bonding or cementing agents (excluding adhesives for dentures)

          o   Dental impression materials

          o   Artificial teeth

          o   Fluoride varnish

            -          Positive Airway Pressure (PAP) devices

      1.3   The criteria for exemption from registration may be applied under the following conditions. However, the person subject to these criteria must submit an application for notification in  accordance with Section 27 of the Medical Devices Act, B.E. 2551 (2008).

              1.3.1         manufacturing, importation or sale of medical devices by State agencies in the discharge of duties in connection with the prevention, diagnosis or treatment of diseases or the  rehabilitation and the Thai Red Cross Society

              1.3.2         the manufacture of medical devices specifically for the purpose of sterilisation in medical establishments under the law on medical establishments

              1.3.3         the manufacture or sale of medical devices manufactured by medical and public health practitioners for their particularly individual patients or animals             

              1.3.4         the sale of medical devices, in respect of which a licence, a specification declaration certificate or a notification certificate has been granted, by medical establishments or medical and public health practitioners for their particularly individual patients or animals

              1.3.5         the manufacture or import of medical devices in the quantity meeting the necessity for personal use, for use as samples, for an exhibition or for use in studies, research, analysis or  tests of the quality and standards

              1.3.6         the import of medical devices for particularly individual patients or animals

              1.3.7         the manufacture of medical devices as samples for export

              1.3.8         the manufacture or import of medical devices in accordance with the rules, procedures and conditions prescribed in the Notification of the Minister with the recommendation of the Commission                               

2.      Do I need a Thai representative to apply for any medical device registration?

For foreign entity or individual, you are required to appoint a local authorized representative in Thailand for medical device registration. The representative must be a Thai resident or a legally registered entity in Thailand.

3.      How do I know if a product is a medical device or not?

The definition of medical device can be found int the  following link However, if you are unsure or unclear about whether a product qualifies as a medical device in Thailand, you can submit an application for product identification.

To determine whether a product is classified as a medical device, it is necessary to have clear and detailed information from the manufacturer or product owner, such as labels, user manuals, and accompanying documentation. This information will be used to assess whether the product's intended purpose and usage align with the definition of a "medical device" as stated in Section 4 of the Medical Device Act, B.E. 2551 (2008) and its subsequent amendments.