On June 4, 2024, the Thailand Food and Drug Administration (TFDA) announced the list of foreign agencies recognized or accepted for inspection or certification of medical devices or its establishments. The details are as elaborated below:
| No. | Agency | Condition | |
|---|---|---|---|
| 1 | Therapeutic Goods Administration (TGA) | It is a medical device that has been approved to be registered by one out of the five agencies, with a period of approval to be registered 1 (one) year or more, and it is not a medical device that received the approval in exemption of evaluation on the safety and performance of medical devices. | The intended use, indication, labeling, instructions for use, and packaging of the medical device shall be the same version under condition number 1 (one) once submitted. |
| 2 | Health Canada | ||
| 3 | European Union Notified Bodies (EU NB) | ||
| 4 | Japan Ministry of Health Labor and Welfare (MHLW) | ||
| 5 | US Food and Drug Administration (US FDA) | ||
| 6 | World Health Organization (WHO) | It is a medical device that has been approved or registered in the WHO Prequalification of In Vitro Diagnostic (WHO PQ IVD) program with a period of approval 1 (one) year or more and it is not a medical device that received the approval in exemption of evaluation on the safety and performance of medical devices. | The intended use, indication, labeling, instructions for use, and packaging of the medical device shall be the same version under condition number 1 (one) once submitted. |
| 7 | Health Sciences Authority (HSA) | It is a medical device that has been approved or registered by the Health Sciences Authority (HSA), Singapore under the Thai FDA – Singapore HSA regulatory Reliance Program and it is not a medical device that received the approval in exemption of evaluation on the safety and performance of medical devices from HSA. | The intended use, indication, labeling, instructions for use, and packaging of the medical device shall be the same version under condition number 1 (one) once submitted. |
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