Medical Devices Regulatory Services
in Thailand

Overview

Thailand is one of the major markets for Medical Device in South East Asia. Medical Devices in Thailand are regulated by the Thailand Food and Drug Administration (TFDA) under the Ministry of Public Health (MOPH), Thailand.

Regulatory Authority: Thai Food and Drug Administration (TFDA)

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

Authorized Representative: Taiwan Agent required

QMS Requirement: ISO 13485:2016

Assessment of Technical Data: Medical Device Control Division (MDCD)

Validity of License: 5 Years

Labeling Requirements: Section 44, Medical Device Act of 2008

Submission Format: Paper

Language: English & Thai

Thailand Medical Device Classification

The Thai FDA classification system is reverse to that of the US FDA with Class I devices having the highest risk, Class III devices are referred as “general devices”, and Class II referred as “notification”. Additionally, import of used/refurbished equipment is prohibited in Thailand.

Type of Device

Class

Risk

Licensed Medical Devices

Class I

High

Notified Medical Devices

Class II

Moderate

General Medical Devices

Class III

Low

Thailand Legal Representative

For foreign medical device companies that do not want to set up their own subsidiary or trust a local distributor with their product registration information, an independent third party acting as Thai legal agent is the best choice. Employing a Thai third party local agent to register medical products with the TFDA and to act as Thailand Legal Representative allows the manufacturer to easily change distributors.

Thai FDA Medical Device Registration

The Regulation and the registration requirements vary with the type of device. The dossier for Class II and class III devices must be in accordance with a CSDT format.

Licensed Medical Devices such as, condoms, examination gloves, syringes, HIV test kits must show compliance with the Thai Industrial Standards and require license for sale. In certain cases, the devices may have to undergo testing by the TFDA.

Notified Medical Devices such as, physical therapy devices, alcohol detector, implanted Silicone breast prosthesis must obtain product notification by the TFDA.

General Medical Devices account for 90% of the Medical Devices must be validated by the TFDA.

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between the TFDA and the manufacturer
  • Importation Management

Freyr as leading Regulatory consultant can assist you through the Thai registration and licensing processes and secure approval for your Medical Device in the shortest possible time frame.

Summary

S.No.

Device Type

Class

Risk

Registration Pathway

TFDA Timelines

Validity

1.

Licensed Medical Devices

Class I

High

License for sale

8 - 10 Months

5 Years

2.

Notified Medical Devices

Class II

Moderate

Notification

6 - 9 Months

5 Years

3.

General Medical Devices

Class III

Low

Validation with TFDA

7 - 10 Days

Depends on validity of FSC

Expertise

Freyr Expertise

  • Regulatory Due-Diligence
  • Regulatory Intelligence (RI) 
  • Device Classification and grouping 
  • Notification for Notified Medical Devices
  • Registration for Licensed Medical Devices
  • Validation services for General Medical Devices
  • Legal Representation 
  • Labeling support
  • Translation support
  • Distributor identification and qualification 
  • Post Marketing Surveillance 
  • Post Approval Change Management