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Medical Device Registration and Approval in Thailand
General country-specific regulatory information is provided on this page for medical device registration and approval in Thailand.
Last updated on January 16th, 2023.
Medical Device Regulations and Classification in Thailand
REGULATORY AUTHORITY:
Medical Device Control Division (MDCD) of Thai Food and Drug Administration (TFDA) working under Ministry of Public Health.
CLASSIFICATION SYSTEM:
Medical Devices and IVDs:
- Class 1 (listing medical devices)
- Class 2 (notified medical devices)
- Class 3 (notified medical devices)
- Class 4 (licensed medical devices)
TIMEFRAME:
E-submission:
- 30 days – class 1 (non-sterile, non-measuring)
- 200 days – class 1 (sterile, measuring)
- 250 days – class 2 & 3
- 300 days – class 4
SPECIAL REQUIREMENTS:
On-Site Audit: on-site audit only required for a novel medical device that require a technological assessment.
Local Tests/Permit: In-country local testing is only required for HIV-related test kit.
Local Clinical Evaluation or Studies: Not applicable
LOCAL FEES (New Application):
- Class 1 (listing medical devices): USD 100.
- Class 2/3 (notified medical devices): USD 1,500.
- Class 4 (licensed medical devices): USD 2,500.
LOCAL FEES (Manufacturer):
The establishment who wishes to import medical devices to Thailand shall apply for a medical device Importing Establishment License. Any establishment who wish to sell licensed medical device shall apply for a License to Sell.
LICENSE VALIDITY:
5 years
LICENSE TRANSFER:
License transfer would not be necessary as the foreign manufacturer can have more than one license holder for the same product. However, any changes (including change of the name of license holder) must be notified to the Thai FDA.
AUTHORIZED REPRESENTATIVE:
The foreign manufacturer should appoint a company located in Thailand to become their representative.
ADDITIONAL INFORMATION:
- As of August 2022, the new registration process (e-submission) consists of 2 stages: dossier screening and dossier review.
- There are 2 fast track options:
- Concise evaluation route (class B, C and D) – product with prior approval from reference agencies (such as TGA – Australia, HC – Canada, EU Notified Body, MHLW – Japan, and FDA – the US)
- Singapore fast track route (class B, C and D) – product with prior approval from HSA Singapore.
For more information on Medical Device Registration in Thailand, check out the following article: Country at a glance: Thailand.
For detailed device-specific compliance information for each market, including Thailand, to expedite the preparation of your medical device or IVD registration application.
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