Thailand
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY
: Medical devices are regulated by the Thai Food and Drug Administration (FDA).

CLASSIFICATION SYSTEM: Devices are classified into the following classes: Class I (Licensed Medical Devices, Highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).

TIMEFRAME: The approval process after file submission takes about eight to ten months for Class I devices, six to eight months for Class II devices up to ten days for Class III devices.

LICENSE VALIDITY: For Class I and Class II medical devices, the product license is valid for five years. For Class III devices, it depends on the validity of the Certificate of Free Sale. 

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: The Thai FDA plans to re-classify medical devices based on the level of associated risk to comply with the ASEAN Medical Device Directive.

Last updated on January 22, 2018.



Interested in obtaining fast market approval for your medical device or IVD in Thailand? REQUEST A FREE QUOTE>

For more information on registration in Thailand, check out the following articles on our blog:
Country at a Glance: Thailand
 
 
latest news
  • Aug 16 2018
    REGULATORY UPDATE - VIASONIX

    Canada: Viasonix' Dolphin family of products was approved for sale with LICENSALE.COM®....

    Read More
  • Aug 8 2018
    REGULATORY UPDATE - ORASURE TECHNOLOGIES

    Nepal: OraSure Technologies' OraQuick HIV Self-Test was approved for sale with LICENSALE.COM®....

    Read More
  • Aug 2 2018
    JOB POSTING: CLIENT MANAGER

    Arazy Group Consultants Inc. is currently seeking qualified applicants for the position of Client Manager. ...

    Read More
  • Jul 17 2018
    REGULATORY UPDATE - ORASURE TECHNOLOGIES

    Mozambique: OraSure Technologies' HIVST test kit was approved for sale with LICENSALE.COM®....

    Read More
  • Jul 16 2018
    REGULATORY UPDATE - DR. KORMAN LABORATORIES

    Colombia: Dr. Korman Laboratories' Dermal Fillers were approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP