Thai FDA Improves Medical Device Application Process

New Expedited Regulatory Applicant Certification Program and Priority Track Pathways Aim to Speed Up the Approval Process

In a meeting on June 19, 2023, the Thai Food and Drug Administration (TFDA) outlined new measures to improve the medical device registration application program.

The six key initiatives discussed included:

1. New Expedited Review for Certified Applicants: The TFDA Foundation will organize a training course to certify the competency of medical device registration applicants (RAs). Once an RA has completed the training, they will be given a certification number which can use when submitting applications, initiating a faster review process. They expect to start the certification course sometime in August 2024. Asia
2. Pre-screening is Now Optional: As of July 1, 2023, the pre-screening step in the medical device registration applications process will be made optional. This change will speed up the process for applicants by at least seven days. Applicants will have the option to undergo the pre-screening process or proceed directly with submitting applications.
3. Resubmission of Rejected Applications: From June 19, 2023, applicants can resubmit previously rejected applications and the TFDA 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 resubmission process more efficient and seamless and reduce overall review times. A new application fee will be required to re-submit, but this cost is nominal (approximately US$70 for risk class 1 and US$370 for risk class 2 or 3 and US$667 for risk class 4).
4. New Priority Review Track Established for Devices with Urgent Public Need: As of June 19, 2023, registration applications for specific types of medical devices will be able to opt for a priority track that will speed up the review process for critical medical devices. 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
5. Submission Strategy Planning: Starting approximately January 2024, the TFDA will encourage applicants to send their submission strategy to TFDA in advance. This will allow TFDA officials to anticipate their workload and better plan their resources accordingly, further streamlining the application management process. Asia Actual expects that this option will be exercised mostly by large multinationals with extensive product portfolios to manage.
6. Registered Certification Body Review: The TFDA also announced that it is looking at options for working with external expert bodies. While this option is still in the proposal stage, these entities could potentially act like notified bodies (NBs) or conformity assessment bodies (CABs) to provide an expedited review option for an additional fee. We expect this new program to be similar to third-party review systems in Europe, Japan, Korea, or Malaysia. Asia Actual will continue to monitor developments on this issue due to its potential impact on the cost and time for market access in Thailand.