Local Labeling Services

Medical Device Labeling in Thailand

Medical device labeling requirements in Thailand are addressed by the Ministry of Public Health’s Notification 137, Section 260 D, “Rules, Procedures and Conditions for Labels and Package Inserts of Medical Devices” details the requirements for labeling Medical Devices in Thailand.

  • Medical device labeling must be in either Thai or English if they are used directly by the physicians. Devices intended for home use must be labeled in Thai.
  • If the required information is not present on the label, a package insert can be added to the product. Package inserts can be in paper or electronic form (including CD, QR code or a website).
  • The importer can affix the necessary labeling within 180 days of the medical device entering the country.