The Thai FDA will now evaluate device approval more efficiently if the device has been already approved in Singapore. This also applies to Class B-D IVD’s approved in Singapore. Basically, the Thai FDA will reduce their review time from 150 to 60 days, and registration fees will be reduced by about 50,000 Thai baht. To expedite the process, the applicant submits a request, provides documents that were already submitted in Singapore including the Singapore registration certificate, and signs a consent form allowing the Singapore HSA to send their device evaluation to the Thai FDA.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.