Thailand: Thai FDA Streamlines Medical Device License Renewals (effective from 22 July 2025)

The Thai Food and Drug Administration (FDA) recently announced new regulations to streamline the process of renewing licenses for medical device manufacturers and importers. According to the announcement, this new measure will be effective starting from 22 July 2025 aims to simplify the renewal process by exempting certain documents and evidence.

Reducing Red Tape for License Renewals

Under the new regulations, the FDA may allow applicants to omit specific information and documents when applying for a license or a detailed notice renewal. This is especially helpful for those who cannot complete their renewal due to pending design verification or risk analysis.

The exemptions apply under these key conditions:

• Medical devices have not caused any serious adverse events

• There has been no abnormal function that could lead to serious adverse events

• The device’s quality, efficiency, and safety are not under suspicion

  
  

This new rule is a welcome change for businesses, as it helps prevent delays in license renewals.

Which Documents Are Now Exempt?

For qualified applicants, the following documents are no longer required for license or detailed notice renewal:

• Summary of design verification and validation

• Risk analysis documents

• Documents on the disposal method of the device after use

  
  

These exemptions are based on regulations from 2020 and 2021. They are designed to reduce repetitive submissions and simplify the renewal process, especially when information has already been certified by foreign regulatory agencies recognized by the Thai FDA.

Step Towards Greater Convenience

This change marks a significant effort to facilitate and improve convenience for medical device operators in Thailand. By removing unnecessary bureaucratic hurdles, the Thai FDA is making it easier for companies to comply with regulations, ensuring that safe and effective medical devices remain available on the market.

Source: Food and Drug Administration (FDA)