Medical Devices Regulatory Support in Thailand

Overview

Thailand is one of the major medical device markets in Southeast Asia. Medical device registration in Thailand is regulated by the Thailand Food and Drug Administration (Thailand FDA) under the Ministry of Public Health (MOPH), while the assessment of the technical data is done by the Medical Device Control Division (MDCD).

Medical Device Classification

In Thailand, Medical device classification is carried out in five (05) categories.

Class

Risk

Application type

Class I

Low-risk

Listing (Self-declaration)

Class II

Low- to moderate-risk

Notification Common Submission Dossier Template (CSDT)

Class III

Moderate- to high-risk

Notification (CSDT)

Class IV

High-risk

License (CSDT)

 

Medical Device Registration

The requirements for medical device registration in Thailand vary with the device class. The low-risk Class I devices must be listed before they are imported and marketed in Thailand, whereas the Class II and Class III devices must be notified. The Class IV devices must follow the regulations of the Thailand medical device registration process and have an approved license with the Thailand FDA to place them in the Thai market. The Thai medical device regulations also state that the Class II, III, and IV devices require the submission of technical dossiers as per the Association of Southeast Asian Nations (ASEAN) Common Submission Dossier Template (CSDT) format. The Class I sterile and measuring devices require the submission of testing reports for medical device registrations in Thailand.

All devices registered in Thailand after February 15, 2021, shall comply with the new medical device regulations and shall have their technical files compiled in the CSDT format. The devices currently approved under the old regulations shall be renewed as per the new Thai medical device regulations. These devices, however, have a grace period based on the expiry of the existing Thailand FDA medical device approvals.

The Class II, III, and IV devices with their certificates due for expiry within one (01) year from the date of the announcement have to be renewed by February 15, 2022. Referred to as Partial I, this partial renewal requires less documentation, and the renewed import license would be valid for three (03) years.

The class II, III, and IV devices due for expiry after a year from the date of the announcement, i.e., in 2022 and beyond, can submit the applications to the Thailand FDA within three (03) years, and these require a majority of the CSDT documents to be submitted. Referred to as Partial II, the import licenses renewed under this pathway will be valid for five (05) years.

Freyr Expertise

  • Medical device registration in Thailand
  • Regulatory due-diligence and Regulatory Intelligence (RI) services
  • Thailand medical device classification and grouping services
  • Listing services for low-risk devices
  • Notification services for moderate-risk devices
  • Transition for new medical device regulations compliances
  • Licensing services for high-risk devices
  • Legal representative services
  • Labeling services
  • Translation services
  • Distributor identification and qualification services
  • Post-marketing surveillance services
  • Post-approval change management
  • License renewal and transfer services
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