Recognizing the critical importance of Mpox testing, the Thai FDA has implemented a preliminary assessment form to proceed the evaluation of diagnostic test kits announced on August 20, 2024. This streamlined process allows manufacturers and importers to navigate the initial registration steps more efficiently, facilitating the rapid availability of these essential medical devices.
Diagnostic Kit Categories
Mpox diagnostic test kits have been classified as In Vitro Diagnostic Medical Devices (IVD MD) and designated as Notified Medical Devices (Class 2-3).
The Thai FDA has categorized Mpox diagnostic kits into two primary types:
- Molecular Diagnostic Test (Professional use)
- Antigen Diagnostic Test (Professional use)
These classifications align with the guidelines from the Department of Medical Sciences and the Department of Disease Control.
Process for Registration of Mpox Diagnostic Test Kits
- Dossier preparation: Compile the dossier according to the evaluation form for each type:
- Molecular tests: Refer to the guidelines on media.php (moph.go.th)
- Antigen tests: Refer to the guidelines on media.php (moph.go.th)
- Submission: Submit the application via the e-submission system.
- Compliance: The applicant must respond to one compliance request within 15 calendar days
- Thai FDA Review: The Thai FDA will assess whether to send the application to a third-party specialist for further evaluation.
- If not: The application will be approved.
- If yes: The applicant must respond to an additional compliance request from third-party specialist within 15 calendar days.
- Approval Decision: After completing the necessary compliance steps, the Thai FDA will make an approval decision regarding the registration of the diagnostic test kits.
Current Limitations
Due to technical limitations in developing rapid antigen test kits and the continuous mutation of the virus, the Thai FDA has not approved any self-test kits for home use. This decision is in line with guidance from the World Health Organization (WHO) and stringent regulatory bodies such as the USFDA. Additionally, diagnostic kits and reagents for Mpox are not yet widely registered for commercial distribution, and evaluation criteria may evolve as new information and advancements in diagnostic technology become available.
Conclusion:
The registration process for Mpox diagnostic test kits, classified as IVD MD (Class 2-3), follows a structured and efficient pathway. Applicants must prepare dossiers specific to the type of test, submit through the e-submission system, and comply with Thai FDA or third-party specialist requests within set timeframes.
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References:
Process and Documentation for the Registration of Diagnostic Tests for Monkeypox