Thai FDA has announced the requirements for labeling of Licensed medical devices, Notified medical devices, and Listing registration numbers. Previously, there were no strict requirements for medical device labeling but this regulation stipulates the information that needs to be included for these products.

  1. Thai FDA would like to ensure that all medical device risk classifications follow a synchronized format set of registration number display, to avoid any discrepancy in such delivery manner. Hence it is mandatory to display the registration numbers for Licensed medical devices, Notified medical devices, and Listing with 12 digits of Arabic numerals in the frame of the FDA logo without showing any additional message.
  2. Labels for professional use devices are not required to have a Thai version. English labels are sufficient. Meanwhile, for home use devices, labels must be in both Thai and English.
  3. This decree shall be enforced starting from October 31, 2021.
  4. Medical Device Labelling requirements are summarized as follows:


    Labeling details

    Medical device (MD) Definitions

    Professional Use MD (Prepared in English)

    Home Use (Prepared in English & Thai)


    Medical device name


    Medical device description.

    E.g. composition, mechanism, type


    Intended use or indication




    Instruction for use


    Name and address of manufacturing site/importer. In the case of Importer, it is required to specify the name, city, and country of manufacturing site, if it is impossible to display name and city of manufacturing site, then name, city, and country of product owner; and country of manufacturing site shall be displayed instead.


    Registration No. of Licensed Medical Device; Notified Medical Device; Listing Medical Device.


    Name, address, phone number, or others. In case of contact purpose, complaint, or information inquiry.


    Numbers or alphabets indicating manufacturing LOT


    M/Y or Y/M of the expiration date. The year shall be displayed with 4 digits number. In the case of a medical device with an expiration date, it is required to display M/Y and Y/M of the expiration date.


    Storage condition


    Warning, Prohibition, Precaution (If any)


Ministry of Public Health Notification regarding the Implementation of Labelling and Medical Device Document 2020

Qualtech Newsletter: New Guidance Document on Labelling of Medical Device