With the Regulatory Reliance of Thailand FDA and HSA Singapore, the applicants can now proceed with a fast-track route in registering Class 4 Medical Devices with approved registration in Singapore. The applicant will be able to wave the cost on the expert review process, valued at 53,000 THB, and reduce the average review time from 150 working days (WDs) to 60 WDs for both IVD and non-IVD medical devices.
To proceed with the registration under this route, the manufacturer or importer will need to provide the documents listed below and apply for a medical device license through the electronic submission system (e-submission).
(1) The registration documents in the form of CSDT that is identical to the CSDT documents used to register with the HSA agency
(2) The change notification documents that are authorized by the HSA agency (if any)
(3) The letter to request a participation in the Regulatory Reliance Program
(4) The evidence of medical device registration of HSA agency, Singapore.
After receiving an application number in the e-submission system, the registrant in Singapore will need to sign the Consent Form to give permission for to HSA to deliver the evaluation report of medical device to the Medical Device Control Division of FDA Thailand. Then, an officer of Thailand FDA sends the request back to the manufacturer or importer to attach the Consent Form in the e-submission system to proceed with the next steps of the registration process.
The procedure can be illustrated below.
Thailand FDA - HSA Singapore Regulatory Reliance