The Thailand FDA has terminated its pre-submission system as of March 15, 2022
The announcement was made on March 7, 2022, by the Medical Device Control Division of the Food and Drug Administration Ministry of Public Health (MOPH) of Thailand.
Submit an application through E-submission if you are a medical device registrant wishing to check the risk classification and grouping. Expect to pay an application fee of 500 THB (est 15 USD) per application for risk classification and grouping.
The Pre-submission system will cease from March 15, 2022, to March 31, 2022. The process takes effect on April 1, 2022.
Find out more about Thailand’s growing medical device market and how Andaman Medical can help you access it.