Since 1 April 2024 (B.E. 2567), FDA has removed the Breath Alcohol Tester from the List of Medical Devices in order to provide convenience for people in conducting self-tests while maintaining the standardized quality of such devices.

Mr. Lertchai Lertvut, the Deputy Secretary-General of the Food and Drug Administration (FDA) revealed that FDA has changed the regulation on the Alcohol Tester aiming to improve it more suitable by the dissolution of the Notification of the Ministry of Public Health No. 22 (B.E. 2540) Re: Alcohol Testing Device B.E. 2567 in order that the Alcohol Tester could be controlled and regulated regarding the risk-based conditions while responding to the international practice. This enforcement would be effective on 1 April 2024 and as such, it would result in the following:

1. The Alcohol Tester which gauges the level of alcohol from the body fluids for the purpose of medical diagnosis is regarded as the medical device.
2. The Breath Alcohol Tester, which is generally not for medical purposes such as for a person's ability to drive safely, is not regarded as the medical device.

The Deputy Secretary-General of FDA stated more that any entrepreneurs of medical device, being granted the certificate of notified on the Alcohol Tester for the medical purpose as mentioned above, could continue to use such document until its expiry date, and for those who would like to continue their business, had to extend the expiry date before the document was terminated. However, any entrepreneurs being granted the certificate of notified on the Breath Alcohol Tester must return such document with the other important relevant documents to FDA. For more information, please study via the attached QR code.

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News Publication Date: 3 April 2024