Overview

As one of the fastest growing medical device markets in South-East Asia, Thailand imports major share of its Medical Devices. Thai Food and Drug Administration (TFDA) under Thai Ministry of Public Health (MOPH) regulates the Medical Devices in the country. The agency has risk-based classification of 3 classes of which Class I is for high-risk devices and Class III is for low-risk devices. Identifying the right classification plays key role in the process thereafter. Additionally, with the anticipation of Regulatory revamp by the agency, applicants will have to remain prepared for major changes in the years to follow.

Freyr’s experts assist in distinguishing the Device Class and thus to expedite the market approval process. Freyr offers Regulatory assistance encompassing the product lifecycle of Medical Devices and also keeps clients informed about any changes in regulations and prepares them for compliance in time.

Thailand Market Entry for Medical Devices - Process Flow

Thailand Medical Device Regulations

 

Freyr Expertise

  • Medical Device Classification
  • Assistance for Appointing Thai Local Agent
  • Document/Dossier Compilation
  • Post-Market Surveillance

Summary

S. No

Regulatory Parameter

Thailand

1

Regulatory Authority

Thai Food and Drug Administration (TFDA)

2

Regulation

Medical Device Act of 2008 (B.E. 2551)

3

Risk Classification

Class I

Licensed Medical Devices (High)

Class II

Notified Medical Devices (Moderate)

Class III

General Medical Devices (Low)

4

Regulatory Pathway

Class I

License for sale

Class II

Notification

Class III

Validation with TFDA

5

Authorized Representative

Taiwan Agent required

6

Fee payable

$ 3000 - $6000*

7

QMS Requirement

ISO 13485

8

Assessment of Technical Data

Medical Device Control Division (MDCD)

9

Validity of License

5 Years

10

Labelling Requirements

Section 44, Medical Device Act of 2008

11

Submission format

Paper

12

Final Outcome

Class I

License for sale

 

 

Class II

Notification

 

 

Class III

Certificate for custom process

13

Timelines

Class I

8 - 10 Months

 

 

Class II

6 - 9 Months

 

 

Class III

7 - 10 Days

14

Language

English & Thai

*The price is as per records at the time of documentation and is subject to change.