May 19, 2021

Thailand’s Ministry of Public Health, which includes the Thai Food and Drug Administration (Thai FDA or FDA Thailand), issued new medical device regulations in February as part of an effort to align the country’s regulatory system with rules established in the ASEAN Medical Device Directive (AMDD). This directive, signed by the ten member states of the Association of Southeast Asian Nations (ASEAN), set in motion a process to achieve a harmonized regulatory structure for medical devices across the regional organization.

The new regulations increase the regulatory burden on manufacturers by stipulating that full technical data must be provided for all medical devices, a requirement previously applying only to products deemed high-risk. This data is to be submitted using the ASEAN Common Submission Dossier Template format. Along with these requirements comes a new fee schedule with increased application fees.

Contents of new Thai medical device regulations

The following documents (links in Thai) lay out the major features of the new medical device regulations:

More medical device regulatory resources for Southeast Asia from Emergo by UL:

Author

  • Timothy Herr

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