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.

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: 

  • Pre-submission (all classes): 15 days
  • 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 (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.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, Philippines, SingaporeVietnam

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