Medical Device Registration in Thailand

Thailand is a rapidly growing market for medical devices, driven by its expanding healthcare sector and increasing demand for state-of-the-art medical technologies. For international manufacturers, understanding the medical device registration process in Thailand will go a long way in entering this promising market.

All medical devices, whether manufactured domestically or imported, must be registered with the Thai Food and Drug Administration (Thai FDA) under the Ministry of Public Health. Registrations are submitted through the online “E-submission system”.

Why Register a Medical Device in Thailand?

Registering your IVD device in Indonesia offers numerous advantages for your business:

Our Medical Device Registration Services

Registration Services

  • Standard product registration
  • Special access product registration
  • Renewal of product registration
  • Amendment and change notification
  • Product licence withdrawal

Authorised Representative Services

  • Liaison with the local government agency on all regulatory issues, including amendments and change notifications
  • Regulatory monitoring to alert you to any changes or new regulations applicable to your product
  • Licence holding
  • Adverse event reporting and management
  • Product alert and recall tracking
  • Complaint handling

Additional Support Services

  • Regulatory intelligence reports providing insights into market access routes and the latest regulatory landscape in your target market
  • Importation
  • Storage and warehousing
  • Relabeling
  • Online regulatory training

Why Register Your IVD Medical Device in Thailand?

For medical device registration in Thailand, a company must first obtain an Establishment License for manufacturing or importing the device. This licence is issued by the Thai FDA via online submission. Only Thai nationals or locally established companies can apply for an Establishment License.

Foreign manufacturers have three options to register their medical devices in Thailand:

Options for Foreign Manufacturers

Set Up a Legal Subsidiary Entity

 Establish a local company to register the devices. Legal guidance is recommended due to ownership restrictions.

Appoint a Local Distributor

Choose a distributor with an Establishment License (Importer's Licence) to register the devices.

Appoint an Independent Third Party

 Use a certified third party like Andaman Medical to register the devices. Andaman Medical holds a certified Establishment License and can act on behalf of foreign manufacturers.

After selecting a route-to-market and ensuring the local company has the necessary Establishment License, the holder of the Importer’s Licence can proceed to register the medical device with the Thai FDA. Upon approval, the Thai FDA will issue the appropriate certificates or licences. Multiple registrations with different Importer Licence Holders are allowed, but transferring ownership of the Product Licence is not permitted.

Why Register Your IVD Medical Device in Thailand?

For medical device registration in Thailand, a company must first obtain an Establishment License for manufacturing or importing the device. This licence is issued by the Thai FDA via online submission. Only Thai nationals or locally established companies can apply for an Establishment License. Foreign manufacturers have three options to register their medical devices in Thailand:

Options for Foreign Manufacturers

Set Up a Legal Subsidiary Entity

 Establish a local company to register the devices. Legal guidance is recommended due to ownership restrictions.

Appoint a Local Distributor

Choose a distributor with an Establishment License (Importer's Licence) to register the devices.

Appoint an Independent Third Party

 Use a certified third party like Andaman Medical to register the devices. Andaman Medical holds a certified Establishment License and can act on behalf of foreign manufacturers.

After selecting a route-to-market and ensuring the local company has the necessary Establishment License, the holder of the Importer’s Licence can proceed to register the medical device with the Thai FDA. Upon approval, the Thai FDA will issue the appropriate certificates or licences. Multiple registrations with different Importer Licence Holders are allowed, but transferring ownership of the Product Licence is not permitted.

Classification of Medical Devices in Thailand

As of February 2021, medical devices in Thailand are classified into four risk categories for both IVD and non-IVD products:
  • Previous Classification: General, Notified, and Licensed.
  • New Classification:
    • Class 1 – Listing (effective March 17, 2021)
    • Class 2 – Notified
    • Class 3 – Notified (effective February 15, 2021)
    • Class 4 – Licensed
Under the new regulations, all classes (1, 2, 3, and 4) can benefit from grouping into one registration submission application:  
  • Single
  • Family
  • Family of System
  • System
  • Set
  • IVD Test Kit
  • IVD Cluster
For medical device registration in Thailand, various documentation is required, and submissions must be in English. Generally, the following documents are needed:
  • Device description
  • Pre-clinical studies
  • Device labelling
  • Instructions for use
  • Risk analysis
  • Existing regulatory approvals or market authorizations
  • Manufacturer’s compliance with ISO 13485
Certain medical devices require additional permits or registrations from the Thai FDA or other government agencies, especially those containing or transmitting radiation and those with wireless connectivity. Additionally, some specific products must undergo local testing in an accredited laboratory in Thailand.

Registration Process Overview

Recent changes to the medical device registration process in Thailand came into effect in February and March 2021. The process depends on the product’s classification and whether it is a new registration or already registered in Thailand. The validity of the current product licence also affects the process:

Class 1 Listing Medical Devices

Full Submission: New products and registered products with more than 1 year of validity remaining as of February 15, 2021, require a Full Submission and Thai FDA approval before importation.

Classes 2 & 3 Notified Medical Devices and Class 4 Licensed Medical Devices

Certificates for Classes 2 and 3 Notified Devices and Class 4 Licensed Devices are valid for 5 years. Full submission of documents is required, but Partial 2 Submission is now cancelled for pathway registration.

All registrations must be submitted online via the Pre-submission and E-submission systems. The process is governed by the Medical Device Act, B.E. 2551 (2008) and Medical Device Act (Version 2), B.E. 2562 (2019).

Registration Process Overview

Upload necessary documentation to the E-submission system based on the product’s class.

An order of payment will be generated.

Process payment for the application.

The Thai FDA evaluates the submission.

Upload necessary documentation to the E-submission system based on the product’s class.

An order of payment will be generated.

Process payment for the application.

The Thai FDA evaluates the submission.

Typical Fees and Timeline

A fee is payable for each medical device registration in Thailand. This is a non-tax fee. Below are the new fees as of March 2021 and the respective turnaround times for e-submissions.
Item Class 1 Listing Class 2 Notification Class 3 Notification Class 4 License
Application fee THB 500 (~US$17) Effective on: 17th March 2021 THB 1,000 (~US$35) Effective on: 17th March 2021 THB 1,000 (~US$35)
Evaluation fee THB 600 (~US$20) THB 38,000 (~US$1,275) THB 53,000 (~US$1,775)
License fee THB 2,000 (~US$67) THB 10,000 (~US$335) THB 20,000 (~US$670)
Turnaround time 1 - 80 days 250 days 300 days

Why Choose Andaman Medical as Your Medical Device Registration Consultant in Thailand?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for Medical Device Registration in Thailand. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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