Key Takeaways
- Importer Establishment Registration: A domestic company must first obtain a Medical Device Import Establishment License from the Thai FDA.
- 4 Risk Classes: Class 1 (Class A IVD) requires Listing; Class 2 & 3 (Class B & C IVD, and imaging systems like MRI) require Notification; Class 4 (Class D high-risk IVD) requires full Licensing.
- CSDT Dossier Standard: Requires ISO 13485 certification, Declaration of Conformity, risk analysis, analytical/clinical performance evaluation, and stability data.
- IVD Grouping Rules: Products sharing a legal manufacturer and intended category can be grouped under Single, Family, System, IVD Test Kit, or IVD Cluster submissions.
1. Thailand IVD & Medical Device Risk Classification (Class 1 to Class 4)
- Class 1 (Class A IVD): Low risk — submitted via the Listing (จดแจ้ง) pathway.
- Class 2 & Class 3 (Class B & C IVD): Moderate to high risk (including diagnostic analyzers and medical imaging equipment such as MRI scanners under HS 9018/9022) — submitted via the Notification (แจ้งรายการละเอียด) pathway with a full CSDT dossier.
- Class 4 (Class D IVD): Highest risk (such as blood-screening reagents for transmissible agents) — requires a full License (ใบอนุญาต) and laboratory evaluation where applicable.
2. What Is CSDT and How Does IVD Grouping Work?
CSDT (Common Submission Dossier Template) is the harmonized ASEAN technical file format covering device description, design & manufacturing, essential principles checklist, risk management, labeling, and analytical/clinical evidence. Under Thai FDA grouping guidelines, multiple reagents or devices may be bundled into a single application using Family, System, IVD Test Kit, or IVD Cluster rules.
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Once the Thai FDA issues the product registration certificate, every import shipment requires a License Per Invoice (LPI) transmission via Thailand's National Single Window (NSW) matching the commercial invoice models and quantities before customs release.
Official Sources: Medical Device Control Division, Thai Food and Drug Administration (medical.fda.moph.go.th).
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View FDA & Customs Clearance ServicesIn Thailand, medical devices and In Vitro Diagnostics (IVDs) are regulated by the Thai FDA Medical Device Control Division under a 4-tier risk classification (Class 1 Listing, Class 2–3 Notification, and Class 4 Licensing). Technical dossiers must follow the ASEAN Common Submission Dossier Template (CSDT) before per-shipment LPI clearance via Thailand NSW.
Frequently Asked Questions
Q:What does CSDT stand for in Thai FDA medical device registration?
A:CSDT stands for Common Submission Dossier Template, the standardized ASEAN technical documentation format required by the Thai FDA for Class 2, 3, and 4 medical device and IVD submissions.
Q:How are Class A medical devices and IVDs registered in Thailand?
A:Class 1 (Class A) low-risk medical devices and IVDs are registered through the Listing (จดแจ้ง) pathway with the Thai FDA Medical Device Control Division.
Q:What grouping options exist for IVD registration in Thailand?
A:Thai FDA regulations allow IVD submissions to be organized as Single, Family, System, IVD Test Kit, or IVD Cluster applications when specific commonality criteria are met.
