The Thai FDA provides facilitation to the entrepreneurs who registered medical device production or registered medical device importation by reducing the redundancy of some documents, information, and evidence referenced from overseas agencies recognized by the Thai FDA. The reduction of redundancy documents will be effective on 6 June 2024, resulting in faster service on granting medical device permission.

Mr. Lertchai Lertvut, Deputy Secretary-General of the Food and Drug Administration said that in order to drive Thailand’s economy on the medical device industry, the Thai FDA then issued the Notification on providing facilitation to the entrepreneurs by reducing the redundancy of some documents, information, and evidence which would make the consideration on granting the medical device permission faster. This adjustment would be effective on 6 June 2024 so the entrepreneurs submitting the request for the permission on medical device production or importation could submit in the Abridged pathway, referencing evidence from overseas agencies recognized by the Thai FDA, and will be exempt from certain document. This would include the documents on the summary of design verification and validation, the risk analysis and the disposal of device. Since those documents were evaluated by overseas agencies recognized by the Thai FDA. However, this would be eligible for the medical devices which got the granted permission for more than 1 year.

The Deputy Secretary-General of the Food and Drug Administration stated more that FDA adjusted the process of granting permission to be faster with the aim to decrease the redundancy on granting permission while maintaining efficiency and safety of the medical devices. The procedures of granting permission were continually developed in order to enhance the medical device industry to incorporating the latest and modern technology and thus being accepted internationally. Moreover, this would ensure the security and stability to the protection system of medical device consumer in Thailand.

*******************************************
News Publication Date: 6 June 2024