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Thailand Medical Device Registration

Thai Food and Drug Administration (Thai FDA) approval timelines and requirements

2-4 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Thailand Local Agent

Thailand Medical Device Registration Overview

Thailand medical device registration through Thai FDA typically takes 2-4 months for Class 1 devices. The official Thai FDA target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Thailand uses a 4-class (1, 2, 3, 4) risk-based classification system. Foreign manufacturers must appoint a Thailand Local Agent to register devices in Thailand. Registration is valid for 5 years.

Registration Timeline by Device Class

Thailand uses a 4-class (1, 2, 3, 4) risk-based classification system.

Class 1

Notification

Low Risk
Official
1-2 months
Realistic
2-4 months

• Notification-based, minimal review

Class 2

Registration

Medium Risk
Official
3-6 months
Realistic
4-9 months
With Prior Approval
3-5 months

Accelerated with: FDA, EU CE Mark, ASEAN MRA

• ASEAN harmonization applies

Local Testing RequiredGMP/QMS Required

Class 3

Registration

High Risk
Official
4-8 months
Realistic
6-12 months
With Prior Approval
4-7 months

Accelerated with: FDA, EU CE Mark, ASEAN MRA

• Clinical data may be required

Local Testing RequiredGMP/QMS Required

Class 4

Full Registration

Highest Risk
Official
6-12 months
Realistic
9-18 months
With Prior Approval
6-10 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical evidence required

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required
Expedited Pathways

ASEAN Medical Device Directive

Harmonized registration within ASEAN

20-30% faster
Eligibility: Products registered in ASEAN MRA countries
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Thailand registration.

FDA 510(k)
Documentation support
2-3 months
EU CE Mark
Documentation support
2-3 months
ASEAN MRA
Harmonized pathway
2-4 months
Key Requirements
  • Thailand Local Agent
  • Thai labeling
  • Local testing from accredited labs
  • ISO 13485 certification
  • Free Sale Certificate
Registration Validity:

5 years

Registration Process Flowchart

Thailand Medical Device Registration Process

Step-by-step Thai FDA registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by Thai FDA. Appoint a Thailand Local Agent.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to Thai FDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

Thai FDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 months

In-depth technical assessment of device safety and performance. Thai FDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, Thai FDA issues Thailand market authorization certificate.

Summary: The Thailand medical device registration process through Thai Food and Drug Administration (Thai FDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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Related Resources
Thai FDA Regulation NewsGovernment Registration Fees
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.