The Thai FDA regulates the production, import, or sale of medical devices by requiring at least one regulator in charge of the production, import, or sale processes to follow relevant standards and laws under the Medical Devices Act, B.E. 2551 (2008), and its amendments. The regulator must have appropriate qualifications, with their name and qualifications prominently  displayed at the place of production, import, or sale.

Mr. Lertchai Lertvut, the Deputy Secretary-General of the Food and Drug Administration, stated that the Thai FDA places significant importance on regulating the production, import, or sale of medical devices. As a result, a Notification has been issued requiring establishment registrants, licensed medical device registrants, notified medical device registrants, and listed medical device registrants for sale or import must designate at least one regulator at each production or import site. Additionally, the medical device sale permission grantees must provide at least one regulator at each sale location. This requirement ensures that the production, import, or sale of medical devices comply with relevant standards and laws. Regulators must possess the necessary skills and knowledge as specified by their qualifications. It is also mandatory that the names and qualifications of the said regulators be publicly displayed at the place of production, import, or sale.

The Deputy Secretary-General of the Thai FDA added that the designation of regulators at the place of production, import, or sale is an additional measure to ensure that medical devices consistently meet required standards. This initiative aims to build public confidence in the quality and safety of medical devices used in treatments and medical services. Further details can be accessed via the QR Code below.

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News Publication Date: 22 June 2024