Person using a finger prick blood testing medical device

Thailand FDA – HSA Singapore Regulatory Reliance

The Medical Device Control Division, Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health issued an announcement on the Thailand FDA – HSA Singapore Regulatory Reliance implemented for Class 2-4 IVDs and non-IVDs medical devices effective from 1 June 2022.

The registrant in Singapore who obtained the medical device license from HSA agency and wish to participate in the Regulatory Reliance Program must give a permission for the HSA agency to deliver the evaluation report of the medical device to Thai FDA. The benefits shall be obtained from this program are the expert review process and cost could be waived up to 53,000 THB maximum (depends on its risk classification) and turnaround time for the dossier evaluation would be decreased from 150 working days to 60 working days.

You can download the updates in full here:

01.06.2022 Reliance project EN

01.06.2022 ประชาสัมพันธ์เข้าร่วมโครงการ reliance program

 

 

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