In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications.
| Optional Screening Process | Starting from July 1, 2023, the screening process for medical device registration applications will become optional. Applicants will have the choice to undergo the screening process or proceed directly with the application submission. |
| Resubmission of Previously Rejected Applications |
Effective immediately from June 19, 2023, if an applicant intends to resubmit a previously rejected application, the TFDA will resume the review process from where it was previously discontinued. There will be no need to restart the application with a different reviewer, facilitating a more efficient and seamless resubmission process. |
| Certification Course for Medical Device Registration Applicants (RA) |
The Thai FDA Foundation will organize a training course to certify the competency of medical device registration applicants (RA). Upon successful completion of the training, RAs will be granted a certification number. This certification number can be used when submitting applications, enabling a faster review process. The certification course is expected to be introduced around August 2023. |
| Priority Track for Certain Applications |
Starting from June 19, 2023, a priority track will be available for specific types of medical device applications that can provide evidence of necessity. This includes medical devices related to urgent public health problems, life-saving tools, requests from agencies or non-profit organizations, urgent business reasons, and renewal applications with urgent issues. The priority track aims to expedite the review process for critical medical devices. |
| Submission Strategy Planning | Potentially beginning in January 2024, applicants will be encouraged to provide their submission strategy to the Thai FDA in advance. This will allow Thai FDA officials to anticipate their workload and better plan their resources accordingly, further streamlining the application management process. |
| External Expert Bodies (Proposed) |
The TFDA also announced that they were evaluting options for working with External Expert Bodies. While still preliminary, these entities could potentially act like Notified Bodies (NBs) or Conformity Assessment Bodies (CABs) and provide an expedited review option for an additional fee. |
This seems to be a willingness to improve Thailand's medical device registration application management system.
If you have any questions about medical device certification,
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