Expedited Approval Routes for Medical Devices in Thailand

By Sreenu Sattu and Nipapat Phuakyod

The Thai Food and Drug Administration (Thai FDA) has implemented five new expedited routes for medical device and IVD registration to speed up the approval process and streamline market access.

Below, Emergo by UL sources summarize recent and ongoing efforts by Thai regulators to reduce device review and approval timeframes:

1. Pre-screening process and re-submission of rejected applications: Thai medical device market applicants can now re-submit previously rejected applications during pre-screening process and the Thai FDA will resume the review process from where it was discontinued. Applicants will no longer have to restart the application with a different reviewer, which will make the re-submission process more efficient and seamless, and reduce overall review times.
2. Priority track for devices with urgent public need: For medical devices deemed critical for public health, registration applicants may opt for a priority track that will speed up the Thai FDA review process. Applicants who use this route must be able to prove the device’s urgent public need. This option will be available for registrations of medical devices that are:
   • Related to urgent public health problems, such as pandemics
   • Life-saving tools
   • Requested by agencies or non-profit organizations
   • Renewals of previously approved devices that are urgently needed
3. Concise evaluation route: Concise medical device registration filing entails submitting a request based on evidence of registration from a reference regulatory agency that is accepted by the Thai FDA to shorten the approval process for Class 2, 3 and 4 medical devices. In order to meet the criteria for the concise evaluation, the device should have at least one approval from a reference regulatory agency; for medical devices, reference agencies include those in Australia, Canada, the European Union, Japan and the US. For IVDs, Thai regulators accept registrations from reference agencies in Australia, Canada, the EU, Japan, the US and the World Health Organization (WHO).
4.  Screening is now optional: The pre-screening step in the medical device registration applications process has been made optional. Applicants will have the option to undergo the pre-screening process or proceed directly with submitting applications. This change will speed up the process for applicants by at least seven to 10 days.
5. New expedited review for certified RA Applicants: The Thai FDA held its first registration application (RA) certification course (link in Thai) in August 2023, and now offers training courses on a regular basis to certify the competency of medical device registration applicants. Once an RA has completed the training, they will be given a certification number which can be used when submitting applications, initiating a faster review process.

Taken together with the recently launched regulatory reliance program between the Thai FDA and the Singapore Health Sciences Authority (HSA), these developments open the way for streamlined registration timelines and faster medical device market access in Thailand.

Sreenu Sattu is Manager, Quality & Regulatory Affairs Program and Nipapat Phuakyod is Contractor, Digital Product Management at Emergo by UL.