Thailand Medical Device Technical File & CSDT
A CE technical file and an ASEAN Common Submission Dossier Template (CSDT) are not the same document. They share underlying science but differ in structure, required annexes, and language obligations. Thai FDA screens for CSDT format compliance before review begins, and a submission that does not meet format requirements does not advance regardless of the quality of the underlying technical data. DeeMED prepares the CSDT dossier itself, rebuilding the underlying technical file into the correct structure rather than reformatting a CE submission and hoping it passes.
Last reviewed: July 2026
What Is the CSDT (Common Submission Dossier Template)?
Thailand's device submission format follows the ASEAN Common Submission Dossier Template, the harmonized structure used across ASEAN member states under the AMDD. The CSDT is the accepted format for Class 2, 3, and 4 device submissions; Class 1 listing submissions use a simplified document set, with the full CSDT applying to notification and license pathway applications.
Technical documentation within the CSDT may be submitted in English. Application forms and Instructions for Use for home-use devices must be in Thai. The Thai-language obligation applies to specific documents within the dossier, not the entire technical file, so manufacturers with existing CE or FDA documentation can generally submit the underlying technical content in English, provided the CSDT structure, headings, and required annexes are met.
The distinction between having the data and having it in the correct CSDT structure is where most reformatted CE submissions fail. Thai FDA does not flag missing sections and invite revision; a non-compliant submission is rejected at screening and must be resubmitted in full.
What Must the CSDT Submission Package Contain?
The CSDT is organized into defined sections, each with specific content requirements. The following represents the core components of a Class 2, 3, or 4 CSDT submission under Thai FDA requirements.
Administrative documentation
Application form (Thai for home-use devices), Letter of Authorization, the Thai local holder's establishment license, and ISO 13485 certificate for Classes 2, 3, and 4. All must be current at submission; an expired license or certificate blocks the application.
Device description and intended use
Physical characteristics, components, accessories, variants, and the stated intended use as labeled for the Thai market. The intended use governs classification and the clinical evidence standard, and must be consistent with the LOA and the approved labeling.
Design and manufacturing information
Manufacturing process overview, quality control procedures, and evidence of design controls consistent with ISO 13485, structured as a summary sufficient to support classification and clinical evidence, not a full manufacturing dossier.
Risk management
Risk management documentation under ISO 14971, addressing risks specific to the device's intended use in Thailand, not only those identified in the home-market submission.
Clinical evidence
Data supporting the device's safety and performance for its stated intended use. Literature-based justification and equivalence arguments are generally accepted for lower-risk Class 2 devices; Class 3 and 4 devices are expected to show clinical investigation data or robust post-market clinical follow-up. CE clinical evaluation reports and FDA clinical data are accepted as supporting evidence, not a substitute for Thai FDA's own assessment.
Labeling and IFU
Draft labeling and Instructions for Use consistent with the B.E. 2568 (2025) labeling regulation, in force from June 20, 2026. Home-use labels and IFU must be in Thai; professional-use labels and IFU may be in Thai or English. Post-approval labeling changes require a variation submission.
Does CE Marking or FDA 510(k) Clearance Help With Thai FDA Registration?
CE marking under EU MDR and US FDA 510(k) clearance are accepted as supporting evidence in CSDT submissions to Thai FDA. They demonstrate that a device has been assessed by a recognized regulatory authority against defined safety and performance standards, and they carry real weight in the MDCD's expert review.
They are not substitutes for Thai FDA registration. Neither approval shortens the expert review requirement, reduces the CSDT documentation burden, or replaces the classification determination under Thai AMDD criteria. A device that holds both CE marking and 510(k) clearance still requires a complete CSDT dossier, a Thai local holder, an establishment license, and a Letter of Authorization.
The practical value of CE and 510(k) documentation is mainly in the clinical evidence section, where a CE clinical evaluation report or an FDA-reviewed clinical dataset provides a structured foundation for the CSDT's clinical evidence component. The CE technical file structure itself does not map to CSDT sections and cannot be submitted as-is.
The Thailand-Malaysia bilateral reliance program
As of May 1, 2026, Thailand and Malaysia operate a bilateral medical device reliance program. Devices already approved by Malaysia's Medical Device Authority (MDA) may bypass the external expert evaluation step at Thai FDA when submitted with a full CSDT dossier.
The program applies to Thai Classes 2, 3, and 4 (equivalent to MDA Classes B, C, and D); Class 1 is excluded. The applicant must hold a current, valid MDA approval and submit a complete CSDT dossier to the MDCD, with reliance applying specifically to the external expert evaluation step rather than the entire review process.
The program followed a confidentiality agreement signed December 4, 2025 at the 29th GHWP Annual Meeting in Bangkok, preceded by a pilot running February 1 through April 30, 2026. It is currently the only formal, structured bilateral reliance program Thai FDA has with another regulatory authority for medical devices. Thai FDA also runs a less formal, case-by-case reliance practice with Singapore's Health Sciences Authority (HSA), and can treat CE marking or US FDA 510(k)/PMA clearance as supporting evidence for an abridged review on certain device types, but none of these carry the structured pilot-to-full-implementation timeline or reciprocal scope the MDA program has (see our AMDD harmonization and reliance pathway guide for how the HSA/CE/510(k) reliance practice works in more detail).
Post-approval obligations
Thai FDA device registration is not a one-time submission. Approved registrations carry ongoing compliance obligations that fall on the Thai local license holder and, through the holder, on the foreign manufacturer, beginning from the date of approval and continuing for the product's Thai market lifecycle.
Registration renewal
Device registrations require periodic renewal within a defined window before expiration. Renewal for CSDT-pathway devices is generally processed on payment; other renewals require supporting documentation. Confirm the current window and requirements with your local holder before the renewal period approaches.
Variation submissions
Any change to an approved device affecting labeling, intended use, design, materials, or manufacturing process requires a variation submission to the MDCD before the change is implemented in the Thai market.
Adverse event reporting
The Thai local license holder reports adverse events involving the registered device to Thai FDA, with obligations tiered by severity. Thailand participates in the ASEAN harmonized post-market surveillance information exchange, based on the IMDRF NCAR format.
Device discontinuation
Discontinuation of a registered device must be reported to Thai FDA by the local license holder; unreported discontinuation is a compliance failure under the Medical Device Act.
