Thailand Medical Device Approval Process Has Been Simplified With The Removal of the Pre-submission Step

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 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.