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January 24, 2026
Approximately 5 minutes
Thailand FDA Notification on COVID-19 Test Kits and Reagents (2021)
Thailand FDA Notification on COVID-19 Test Kits and Reagents (2021)
1. Issuance and Context
The Notification of the Food and Drug Administration Re: COVID-19 Test Kits and Reagents was issued on 11 January 2021 amid the global COVID-19 pandemic to facilitate timely availability of diagnostic tools while maintaining regulatory oversight. https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf It supplements the Medical Devices Act B.E. 2551 (2008) and related regulations by providing special provisions for SARS-CoV-2 related in vitro diagnostics.
2. Scope of Application
The Notification applies to all COVID-19 test kits and reagents intended for:
- Detection of SARS-CoV-2 nucleic acid (e.g., RT-PCR)
- Detection of viral antigens
- Detection of antibodies (IgM/IgG)
- Point-of-care or self-testing formats
- Reagents and consumables used in such tests https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
It covers importation, manufacturing (if any local), registration, distribution, and clinical use.
3. Regulatory Pathways
To expedite access, the Notification allows:
- Emergency Use Authorization (EUA) — For kits meeting interim performance criteria (sensitivity/specificity thresholds) and supported by WHO, FDA, or equivalent assessments.
- Full registration — Required for continued marketing after initial EUA, with submission of complete technical dossier.
- Importation under special conditions — For research, public health programs, or compassionate use with FDA approval. https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
4. Performance and Quality Requirements
Authorized kits must demonstrate:
- Minimum analytical and clinical performance (e.g., ≥95% sensitivity for PCR-based tests in specified populations)
- Compliance with ISO 13485 or equivalent quality management
- Validation data from recognized laboratories
- Stability and transport condition studies https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
5. Labeling and Information Obligations
Labels and package inserts must be in Thai (or bilingual) and include:
- “COVID-19 Test Kit” designation
- Intended use and limitations
- Storage conditions and shelf-life
- Emergency authorization statement (if applicable)
- Manufacturer/importer details and contact for adverse event reporting https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
6. Post-Market Surveillance
Holders must:
- Report adverse events and performance issues within specified timelines
- Conduct post-market studies if required
- Cooperate with FDA audits and recalls
- Maintain distribution records for traceability https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
7. Enforcement and Validity
Non-compliance may lead to suspension of authorization, product seizure, or penalties. The Notification remained in effect during the declared emergency period and influenced subsequent updates to Thailand’s IVD regulatory framework. https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
This measure enabled Thailand to rapidly expand COVID-19 testing capacity while balancing urgency with safety assurance. https://en.fda.moph.go.th/media.php?id=482123147609513984&name=20210111%20Notification%20of%20the%20FDA%20on%20COVID-19%20Test%20Kits%20and%20Reagents.pdf
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