Medical Device Registration in Thailand

Thailand’s dynamic healthcare market is full of opportunity, but its regulatory landscape can be challenging to navigate. That’s where Andaman Medical comes in.

We simplify medical device registration in Thailand, guiding you through every step to ensure compliance with Thai FDA regulations and a faster market entry. Whether you’re a new player or a global brand, we handle the regulatory process so you can focus on delivering life-changing medical solutions.

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Why Register a Medical Device in Thailand?

Registering your IVD or medical device in Thailand is more than just a regulatory step—it’s your entry into one of Southeast Asia’s most advanced and rapidly growing healthcare markets.

At Andaman Medical, we offer expert regulatory support to help you navigate Thailand’s complex approval process with confidence. From smooth registration to ongoing compliance, we’re your trusted partner at every stage.

Here’s why Thailand is a key destination for your medical device registration:

Access to a Growing Market

Access to a Growing Market

Registering your devices opens doors to Thailand’s expanding healthcare market with rising demand for advanced medical technologies.

Regulatory Recognition and Trust

Regulatory Recognition and Trust

Thai FDA approval boosts your product’s credibility and builds trust among healthcare providers and patients.

Faster Market Entry

Faster Market Entry

Registration helps you enter the market quickly, avoiding delays and capturing opportunities faster.

Gateway to ASEAN Markets

Gateway to ASEAN Markets

Success in Thailand can help you expand into other Southeast Asian markets.

Market Credibility

Market Credibility

Registration enhances your company’s credibility in the market,
making your products more attractive to distributors and partners.

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

1

Set Up a Legal Subsidiary Entity

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

2

Appoint a Local Distributor

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

3

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:
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.
  • 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:
1

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.

2

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.

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
Learn more about the registration of Medical Devices in Thailand
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