The new guidelines focus on the Concise Evaluation and Reliance Program routes, aiming to enhance accessibility while maintaining rigorous evaluation processes for Licensed and Notified Medical Device.

Categorization and Criteria:
Under the updated guidelines, medical
devices are categorized into two distinct groups: those with specific announcements and those without. 

To qualify for expedited evaluation routes, devices must be classified as Class 2, 3, or 4 according to Thai FDA risk classification. Applicants can opt to voluntarily submit under these routes when they meet the following criteria:
Concise Evaluation Route:

  1. Devices must have obtained prior approval from recognized reference agencies such as the Australia TGA, Canada HC, European EU NB, Japan MHLW, US FDA, WHO PQ IVD, for a minimum duration of one year.
  2. The intended use, indication, labeling, instruction for use, and packaging of these devices must align seamlessly with those approved by the reference agencies.
  3. Devices with specific announcements must strictly adhere to relevant Thai FDA announcements.

Reliance Program:

  1. Devices previously approved by Singapore HSA.
  2. The intended use, indication, labeling, instruction for use, and packaging are identical to those approved by the Singapore HSA.
  3. Devices with specific announcements must follow the regulations set forth by the Thai FDA.

Exclusion Criteria:
Devices with a documented history of posing serious threats to public health within a one-year timeframe, as reported in FSCA, Risk Management files, or Risk Analysis, may not qualify for expedited evaluation routes.

Required Documents:
Both routes necessitate the submission of an array of documents, including approval certificates, marketing history declarations, safety declarations, and others as indicated below:

Concise Evaluation

Reliance Program

CSDT dossier

CSDT dossier with change notification that have been approved by Singapore HSA.

Approval evidence from reference agencies

Approval evidence from Singapore HSA

Marketing history declaration

Marketing history declaration

Safety declaration

Safety declaration

Declaration letter on quality/packaging/labeling/instruction for use

Declaration letter on quality/packaging/labeling/instruction for use

Thailand FDA & Singapore HSA Reliance Model Consent Form

Letter of Acceptance for HSA reliance program

Domestic manufacturers not directly owning products must provide a letter of authorization (LOA).

Evaluation Process:
Thai FDA reviewers meticulously evaluate submitted documents to ensure conformity to submissions made to reference agencies, adherence to Thai FDA risk classification, compliance with grouping as per Thai FDA announcements, and alignment with standards. Reviewers reserve the right to request a comprehensive summary of verification and validation reports for further evaluation in case of nonconformity or doubts regarding a device's performance, efficiency, or safety.

Timeframe and Future Aspects:
The timeframe for both evaluation routes is set at 150 days.

The Thai FDA's recent regulatory updates streamline the process for obtaining essential medical devices promptly while maintaining robust safety and quality standards. Prospective applicants seeking to leverage these accelerated pathways should remain informed about these revisions. Stay connected with us to stay informed about any further developments or regulatory amendments in this evolving landscape.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives. 
Connect with us today here to unlock your medical device potential.




Thai FDA Announcement Guidelines