In an effort to expedite the device registration process, the Thai FDA has ended the pre-submission stage of the Thai application process. Previously, applicants for Thai medical device approval had to provide basic information about the product and wait for the TFDA’s response to determine its specific grouping and classification. However, today with the new regulation, medical device manufacturers can now submit a full application, without delay, via the E-submission platform and check the grouping and classification information on this electronic submission platform for a fee of 500 Thai Baht (about 15 USD). This policy change, which is expected to reduce the registration timeframe by about one month, is in line with Thailand’s recent implementation of their new medical device regulations that are aligned with the ASEAN Medical Device Directive.
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.
Source used in the article: https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf