Thai FDA

Thailand - Thai FDA

GuidanceLast updated · 2023Verified · 2026-10-17

Medical Device Act B.E. 2562 + Thai FDA cybersecurity expectations

Authority

Food and Drug Administration, Thailand, Medical Device Control Division

Enforced

2021 (revised MD Act)

Legal framework

Medical Device Act B.E. 2562 + PDPA Thailand + ETDA guidance

FDA package reuse

~75%

Editorial estimate · how →

Scope

All medical devices marketed in Thailand. Cybersecurity guidance applies to SaMD and connected devices.

Pre-market

Risk-class proportional dossier following ASEAN CSDT; FDA / CE approvals accepted as supporting evidence.

Post-market

Adverse-event reporting, software change notifications.

SBOM

Recommended

Encouraged but not mandated.

Vulnerability disclosure

ThaiCERT coordinated disclosure encouraged.

Penalty

Licence suspension, fines, criminal liability under MD Act and PDPA.

Unique requirements

01Thai Authorised Representative
02Thai-language labelling and IFU
03Establishment licence prerequisite

Highlights

ASEAN CSDT template alignment
PDPA Thailand effective 2022
FDA / CE approvals accepted

Aligns with

ASEAN MDD IMDRF N60 ISO 13485

Timeline

2019
Medical Device Act B.E. 2562 enacted
Jun 2022
PDPA full enforcement
2023
Cybersecurity expectations clarified

Key documents

Thai FDA - Software as a Medical Device (SaMD) registration

https://medical.fda.moph.go.th/samd-head/category/samd-03

Thai FDA Medical Device Control Division

https://medical.fda.moph.go.th/

How to submit in Thailand

Playbook reviewed · 2026-07-16

Submission route

Thai FDA licence under the Medical Device Act B.E. 2562

Thai FDA accepts GHTF founding-member approvals. Cybersecurity documentation is not separately mandated but recommended for connected devices.

Authority portal

Step-by-step

Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
Step 02
Reuse FDA or CE package as baseline
Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.
Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
Step 04
Submit + track queries
Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.

Evidence checklist

Item	Level	FDA equivalent	Notes
Cybersecurity documentation (baseline FDA or CE)	Required	SPDF
Local authorised representative agreement	Required	—
Local-language labeling and IFU	Required	—
SBOM	Recommended	—	Not mandatory but reduces clarification rounds.

Common Thai FDA rejections

No Thai licence holder appointed

Common

Fix · Contract a Thai entity holding an importer or manufacturer licence.

Typical timeline

End-to-end window: 4-8 months

Phase 01

Local rep + dossier prep

2-4 months

Phase 02

Regulatory review

4-8 months

Phase 03

Approval + market entry

1-3 months

Related markets

Egypt

~75% FDA reuse

United Kingdom

~80% FDA reuse

Taiwan

~80% FDA reuse

South Africa

~80% FDA reuse

Frequently asked about Thailand

Is SBOM required for medical devices in Thailand?

Recommended. Encouraged but not mandated.

What does Thai FDA require for pre-market cybersecurity?

Risk-class proportional dossier following ASEAN CSDT; FDA / CE approvals accepted as supporting evidence.

What are the post-market cybersecurity obligations under Thai FDA?

Adverse-event reporting, software change notifications.

What is the penalty for non-compliance with Thai FDA cybersecurity rules?

Licence suspension, fines, criminal liability under MD Act and PDPA.

How much of my FDA cybersecurity package is reusable in Thailand?

Roughly 75% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).