Thailand FDA and Singapore HSA Collaborate on Expedited Medical Device Registration Program

The Food and Drug Administration (FDA) of Thailand and Health Sciences Authority (HSA) Singapore have formed an expedited program to support the registration of medical devices in Thailand. The latest information has been released on their website (July 2022). 

The Medical Device Control Division of the Thai FDA recognises HSA as a reference agency and will perform assessments of any qualified medical device by considering the prior evaluation done by HSA.  

The benefits of using this pathway are reduction of registration fees and a shorter timeline for review. The registrant in Singapore will have to sign a consent form that allows HSA to provide the Thai FDA with the evaluation report of the medical device. 

More details can be found in “Thailand FDA – HSA Singapore Regulatory Reliance, July 2022”:  

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