Guidance & Resources

Thai FDA · MDCD · CSDT templates · Positive List · e-Submission

Key Thai FDA / MDCD Documents

Document	Content	Where to Find
CSDT Full format template	Mandatory dossier format for Class 2–4	Thai FDA website
Class 1 Listing form	Application form for Positive List devices	Thai FDA website
Positive List — Class 1 devices	Current list of devices eligible for Listing pathway	Thai FDA website (updated periodically)
Grouping guidance	Eligibility rules for Family/System/Set/IVD grouping	Thai FDA website
Classification reference list	MoPH classification notification and examples	Thai FDA website
e-Submission portal guide	How to register and use the Thai FDA online portal	Thai FDA website
Fee schedule	Registration, Establishment License, and renewal fees	Thai FDA website

Processing Timelines by Pathway

Pathway	Standard Route	Concise/Reliance Route
Class 1 Listing	Days–weeks (automatic)	N/A
Class 2–3 Notification	2–4 months	1–3 months
Class 4 License	4–8+ months	3–5 months

Note: Timelines are approximate and subject to Thai FDA workload, dossier completeness, and device complexity.

ISO Standards Quick Reference

Standard	Required For
ISO 13485:2016	All Class 2/3/4 — manufacturer QMS
ISO 14971:2019	All registered devices — risk management
IEC 62304	SaMD — software lifecycle
IEC 62366-1	Usability engineering
ISO 10993 series	Biocompatibility
IEC 60601-1	Active/electrical devices
IEC 60601-1-2	EMC

Official Source

All forms, templates, Positive List, and guidance: Thai FDA website — www.fda.moph.go.th → Medical Devices section → MDCD

Download fresh versions

The Positive List is updated when new Class 1 devices are added. Always download the current version before assuming a device is eligible for Listing.

Modify the Class 1 Listing row note to read: 'Class 1 Listing: Days–weeks (automatic upon verification of eligibility on Positive List; no Concise route available as Listing is administrative, not technical review)'