CSDT & Technical Documentation
TH-Unique · Common Submission Dossier Template · ASEAN AMDD aligned
What Is the CSDT?
The Common Submission Dossier Template (CSDT) is the ASEAN-standard dossier format adopted by Thailand for all Class 2, 3, and 4 medical device registration applications. It provides a consistent structure aligned across ASEAN member states, meaning a dossier prepared for Thailand is largely reusable for Malaysia, Philippines, Indonesia, and other ASEAN markets.
CSDT Full Format — For Class 2, 3, and 4
The CSDT Full format is required for all Notification (Class 2–3) and License (Class 4) applications. Class 1 Listing uses a simplified form.
Dossier Structure
| Section | Content |
|---|---|
| Administrative section | Applicant details, product identification, application type, Establishment License reference |
| Device overview and description | Intended purpose, operating principle, materials, configurations/models covered |
| Classification justification | Class assignment with reference to applicable MoPH classification rules |
| Essential principles checklist | Mapping of each essential principle to compliance evidence |
| Design verification and validation | Bench test reports, laboratory testing evidence |
| Risk management | ISO 14971 summary — hazard identification, controls, residual risk |
| Clinical / performance evaluation | CER (general devices) or performance evaluation report (IVDs) |
| Labelling | Proposed Thai labelling and IFU — compliant with MoPH Notification 137 |
| QMS evidence | ISO 13485 certificate — valid, scope-appropriate, accredited CB |
| Manufacturing information | Manufacturing site details, GMP evidence |
| Post-market surveillance plan | PMS commitments for Class 3–4 |
QMS Requirements — ISO 13485
ISO 13485 certification is required for all Class 2, 3, and 4 registrations:
- Certificate from an internationally accredited certification body
- Scope must cover the specific device category
- Current at time of submission
- Covers the manufacturing site
Thai FDA recognises certificates from internationally accredited CBs — no separate Thai FDA QMS approval process.
Essential Principles of Safety and Performance
All devices must comply with the ASEAN AMDD Essential Principles as required by Thai FDA. Key areas:
| Principle Area | Key Standards |
|---|---|
| General safety | ISO 14971 risk management; benefit-risk analysis |
| Biocompatibility | ISO 10993 series |
| Sterility | ISO 11135, 11137, 17665 as applicable |
| Active devices — electrical safety | IEC 60601-1 and sub-parts |
| Software | IEC 62304 (lifecycle), IEC 62366 (usability) |
| Performance | Device-specific standards |
| Electromagnetic compatibility | IEC 60601-1-2 |
Risk Management — ISO 14971
Every CSDT must include a risk management summary:
- Hazards identified for the specific device and intended use
- Risk estimation (probability × severity)
- Risk control measures implemented
- Residual risk evaluation
- Benefit-risk analysis — benefits must outweigh residual risks
Clinical Evidence
| Class | Clinical Evidence Expectation |
|---|---|
| 2 | Literature-based review; performance data; clinical evaluation report |
| 3 | Detailed CER; clinical investigation data may be required for novel technologies |
| 4 | Comprehensive clinical data; usually includes clinical investigation results |
| IVDs | Performance evaluation: sensitivity, specificity, precision, accuracy, stability, reference interval |
Overseas clinical data is accepted where the patient population, disease epidemiology, the Thai FDA may request additional data or bridging studies if significant demographic or epidemiological differences exist. and intended use are equivalent to Thai context.
In-Country Testing — TH-Unique
For certain device categories, Thai FDA may require local testing to be conducted in Thailand:
- High-risk IVDs — potential requirement for local testing
- Medical gloves — local testing may be required
- Determination is made case-by-case by Thai FDA
Confirm whether local testing is required for your specific device type before finalising your dossier preparation timeline.
The CSDT section appears complete but should clarify: 'Grouping reduces but doesn't eliminate documentation requirements. Even in a grouped application, each device variant must be adequately described and its characteristics documented. The CSDT must cover the full range of variants with clear model-specific identification.'