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The Health Ministry of Thailand strives to maintain the optimum quality of life and takes all the necessary measures to assure the health and safety of its people. Recently, the TFDA has amended the medical device regulations to meet the highest safety standards and quality of devices entering the Thailand market. The device labeling is a critical communication channel that educates the end-user and patient about safety, efficacy, and instructions for using a given device.
In November 2020, TFDA released an announcement on medical device labeling requirements. The implementation of the same shall start from October 31, 2021, and all the medical devices marketed or placed in Thailand shall comply with these requirements. However, reusable surgical medical devices and equipment are exempted from this requirement. Also, this announcement is not applicable for:
- Certain medical devices that have their labeling requirement
- Manufacturing/importation of medical devices for exportation
- Manufacturing/importation of medical devices exempted under section 27 of the Medical Device Act B.E. 2551 and its amendment (issue 2) B.E. 2562
The announcement encompasses some definitions and specifications for labeling for device registration in Thailand. Applicants/medical device licensee must prepare the labeling in Thai or English (according to the intended use) language within one-eighty (180) days of the customs clearance.
The key considerations for the TFDA medical device labeling requirements are:
- Home use medical devices – A layman can use these devices, where the medical practitioner has advised the patient to use them outside the medical facility. The labeling of home-use medical devices must be prepared in the Thai language.
- Professional use medical devices – These devices can only be used by healthcare professionals or under a healthcare professional’s supervision. The labeling of professional use medical devices must be prepared in Thai and English language.
- Labeling should display the following details:
Labeling Requirements | Labeling Instructions | ||
Professional use Medical Devices | Home Use Medical Devices | Devices Exempted from the Labeling Requirement | |
Name of the device | Yes | Yes* | Yes |
Device description | Yes | Yes | No |
Intended use | Yes | Yes | No |
Quantity | Yes | Yes | No |
Instructions for use | Yes | Yes | No |
Name and address of manufacturing site/importer | Yes | Yes | Yes |
Registration no. | Yes | No | No |
LOT no./serial no. | Yes* | No | Yes* |
Expiration date (mm/yyyy) | Yes* | No | Yes* |
Storage condition | Yes | Yes | No |
Precautions (if any) | Yes | Yes | No |
Information inquiry | Yes | No | No |
Medical device document | Yes** | Yes# | No |
* In English or English abbreviation format, when labeling details are in abbreviation format, it is mandatory to mention its definition on medical device labeling or medical device document.
** Intended Use, Instructions for Use, Storage Condition, Precautions, and Information Inquiry can be incorporated here if not mentioned on the labeling.
#Manufacturing site details and Storage conditions can be incorporated here if not mentioned on the labeling.
With the new labeling requirements, the TFDA has taken a significant measure to ensure effective communication of medical device information. The labeling requirements are particular, and manufacturers wishing to import their devices to Thailand will have to comply with them from October 31, 2021.
Are you willing to launch your medical devices in Thailand? Would you like to know more details about the TFDA’s medical device labeling requirements? Reach out to a regional Regulatory expert; stay informed, and stay compliant.
