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 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.