Medical Device Registration in Thailand
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?
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.
Our Medical Device Registration Services
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
Why Register Your IVD Medical Device in Thailand?
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.
Why Register Your IVD Medical Device 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.
Classification of Medical Devices 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
- Single
- Family
- Family of System
- System
- Set
- IVD Test Kit
- IVD Cluster
- Device description
- Pre-clinical studies
- Device labelling
- Instructions for use
- Risk analysis
- Existing regulatory approvals or market authorizations
- Manufacturer’s compliance with ISO 13485
Registration Process Overview
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.
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
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 |