On 20th June 2022, the TFDA (the Thai FDA) established the expansion of the Singapore Reliance Route programme, initially tested only with Class D/Class 4 products, to all Class B, C and D Medical Devices.
Effective immediately and enjoying the preferential pathway, the Thai FDA will review applications in a maximum of 60 working days for the devices that meet the eligibility requirements, which are:
- Passing the approval process in order to be marketed in Singapore at HSA;
- Being actively listed in the Singapore Medical Devices Register;
- Using the Common Submission Dossier (CSDT) format to apply for market access.
How to place Medical Devices on the Thai market under licence in Singapore?
Manufacturers must appoint a Thai Authorised Local Representative to submit a standard e-submission application to the Thai FDA’s Medical Device Control Division.
The applications using the Singapore Reliance Route not only will include the exact same CSDT technical documents submitted to the HSA in Singapore but they will also have to involve the Local Representative in Singapore to enable the HSA (Regulatory Authority in Singapore) to send their assessment documents to the TFDA (Regulatory Authority in Thailand).
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Sources:
https://www.fda.moph.go.th/sites/FDA_EN/SitePages/Medical.aspx?IDitem=LawsAndRegulations
