Thailand: Thai FDA issues regulations on quality systems for medical devices

In brief

The Thai Food and Drug Administration (FDA) has recently issued two notifications, namely the Notification of the Ministry of Public Health Re: Good Manufacturing Practice, B.E. 2566 (2023) ("GMP Notification"), and the Notification of the Ministry of Public Health Re: Good Importing and Sales Practice, B.E. 2566 (2023) ("GISP Notification"). These notifications aim to regulate the quality systems of medical device manufacturing facilities, as well as importers and sellers of medical devices.


In more detail

From July 2024, new manufacturers of moderate-risk to high-risk medical devices must comply with the standards specified in the GMP Notification (which includes the obligation to obtain the GMP Certificate, the Thai Conformity Assessment Standard – TCAS 13485 Certificate, or the ISO 13485 Certificate). Manufacturers of low-risk medical devices and medical devices for animals will also be required to improve their manufacturing facilities to comply with the quality systems required under the GMP Notification (though they are not required to obtain the GMP Certificate, the TCAS 13485 Certificate, or the ISO 13485 Certificate).

Under the GMP Notification, manufacturers of moderate-risk to high-risk medical devices who obtained the GMP Certificates under the previous standards before July 2024 may continue their operations without the need to obtain the new required certificates (as outlined above), though they will still be required to comply with the new standards as provided under the GMP Notification. However, the new required certificates must be obtained within the given grace periods.

Importers and sellers of medical devices must start preparing their quality systems for the import and sale of medical devices in accordance with the GISP Notification, which will come into effect on 5 January 2025. By January 2029, all importers and sellers of medical devices must fully comply with the GISP Notification.

For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.

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