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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Thailand, to expedite the preparation of your medical device or IVD registration application.
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.
Medical Devices and IVDs:
- Class 1 (listing medical devices)
- Class 2 (notified medical devices)
- Class 3 (notified medical devices)
- Class 4 (licensed medical devices)
- Pre-submission (all classes): 15 days
- 30 days – class 1 (non-sterile, non-measuring)
- 200 days – class 1 (sterile, measuring)
- 250 days – class 2 & 3
- 300 days – class 4
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 (notified medical devices): USD 1,575.
- Class 3 (notified medical devices): USD 2,375.
- Class 4 (licensed medical devices): USD 3,495.
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
AUTHORIZED REPRESENTATIVE: The foreign manufacturer should appoint a company located in Thailand to become their representative.
Last updated on April 20, 2021.
For more information on Medical Device Registration in Thailand, check out the following article: Country at a glance: Thailand.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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