Medical Device Classification in Thailand is risk-based, as per ASEAN Directive received in 2018 and fully applied from 2021.
According to its function, use, time and risk, a medical device may be classified in 4 categories, numbered from 1 to 4, with a related risk class (16 different rules). According to the result of such assessment, certification process will have different requirements.
You can download here the FULL DOCUMENTATON explaining the risk-based Medical Device Classification in Thailand. Documents are our translation of the official rules issued by Thai FDA. They have mere descriptive purpose and are not aimed at professional use. Contact us for any official assessment about classification of your Medical Device.
Download the document Thai FDA Medical Device Classification
Download the document Medical Device Risk Classification in Thai FDA
Medical Devices risk classification are clearly stated in the official documentation issued in 2021, following the new regulations issued in 2021.
Since then, we receive from new customers always the same question: what is the risk classification of my medical device? We summarize here below the cornerstone of Medical Devices risk classification, so that every manufacturer/importer may be able to understand his own medical device.