The Thai Food and Drug Administration (FDA) has recently updated its regulatory framework, introducing changes designed to streamline the process for device registration in Thailand. These changes, which take effect immediately following their publication in the Royal Gazette, are aimed at simplifying the evaluation of device safety and efficacy documentation, thereby expediting the approval process.
Under the revised notification consistent with the ministerial regulations of B.E. 2564, the amount of documentation for applicants will be significantly reduced. Specifically, for a full registration evaluation, the Thai FDA will no longer need documents such as certification letters regarding intended use, marketing history, safety declarations, or verification of approval from foreign medical device authorities.
For a concise evaluation, applicants are exempt from submitting design verification, risk analysis, and waste disposal documentation, provided the medical device has been registered for over a year with a recognized international body like the US FDA, European Union Notified Bodies, or Health Canada. It’s essential that the medical device’s trade name, intended use, indications, labeling, and packaging remain unchanged from what was originally approved.
These modifications are intended to make it easier for device companies to navigate the regulatory landscape and get their products to market more quickly, without compromising safety and efficiency. However, the Thai FDA maintains the option to request additional documentation if there are concerns about a device’s compliance with these standards.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------