Thailand Medical Device Labeling

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. 

General Device Labeling Requirements

1. Name of the product
2. Information of the medical device such as the main component, Mechanism etc.
3. Indication
4. Quantity 
5. How to use
6. Name and address of the manufacturer or the importer. In case if we were the importer, we must show the name, city and country of the manufacturer or owner of the medical device
7. Medical device license number
8. Name, address and phone number in case the customer need more information or complaints
9. Serial number or Batch number
10. Manufacturing date and expiry date, indicate the year in four digit number (ex.2020)
11. Storage
12. Warnings, contraindications and precautions

Requirements for Home-use Medical Devices

1. Name of the medical device
2. Information of the medical device such as the main component, Mechanism etc.
3. Purpose of use
4. Quantity
5. Name and address of the manufacturer or the importer. In case the importer, we must show the name, city and country of the manufacturer or owner of the medical device
6. Indication, How to Use instructions, Suggestions
7. Storage
8. Warnings, contraindications, precaution
9. Date of the latest version of Package Insert

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.

Exemptions to Labeling Requirements

Medical device used for the surgery that can be reused and certain medical devices specified by the Thai FDA do not have to follow these regulations. 
However, the labels and/or Package Insert must include:

1. Name of the medical device
2. Name and address of the manufacturer or the importer. In case if we were the importer, we must show the name, city and country of the manufacturer or owner of the medical device
3. Serial number or Batch number
4. Manufacturing date and expiry date, indicate the year in four digit number (ex.2020)

Contact Asia Actual to see if our Thailand labeling solutions are right for your needs.