On March 18, 2025, the Thai Food and Drug Administration (TFDA) released a draft amendment regarding the labeling standards, methods, and conditions for medical devices.
Manufacturers, importers, license holders, and those who have reported registration details of medical devices are required to prepare medical device labels and IFU in accordance with these regulations.
The label for medical devices must include the following information:
(1) Product name
(2) Intended use or indications (if it cannot be started on the label, it must be included in the IFU)
(3) Quantity, volume, or packaging unit (as applicable)
(4) Name and address of the manufacturing or importing location. For importers, the name of the manufacturing location, city and country must be displayed. If the name of the manufacturing location and city cannot be provided, the product owner’s name, city, country, and the country of manufacture must be displayed instead.
(5) License number, registration number, or notification number
(6) Manufacturer’s serial number, production date, or model number
(7) If there is no expiration date, the month/year or year/month of manufacture (displayed in four digits)
(8) If there is an expiration date, the expiration month/year or year/month (displayed in four digits), or the usage period from the date of manufacture
* Items (5), (7), and (8) displayed on the label may use English, English abbreviations, or symbols.
For software medical devices, labeling must be provided in electronic form and displayed in either Thai or English (other languages may be used, but the content must be consistent with the Thai or English version). The label and electronic labeling of software medical devices must include the following information:
(1) Product name
(2) Intended use and indications
(3) Essential information about the medical device (e.g., key components, operating principles, type, category)
(4) Name of the manufacturer or product owner
(5) Version number or version identification
(6) Warnings, contraindications, or precautions (if applicable)
(7) Unique Device Identification (UDI), for Class 2 to Class 4 medical devices
* If the software medical device is packaged in physical form, all of the above labeling information may be provided in electronic format within the IFU.
The regulation also includes labeling requirements for reusable surgical or dental medical devices, as well as for home-use medical devices.
A grace period for labeling compliance is provided as follows:
- Final labeling approval must be completed within 30 days after importation and before the product is sold.
- All labels and IFUs must be submitted within 30 days from the date of approval by the quarantine authority.
This regulation is scheduled to take effect the day after its publication in the Royal Thai Government Gazette.
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
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