Thailand medical device registration is managed by the Medical Device Control Division of the Thai Food and Drug Administration (FDA) according to the Medical Device Act B.E. 2551 (2008). While changes are scheduled for later in 2018 that will bring alignment with the ASEAN Medical Device Directive (AMDD), the current regulatory system requires medical devices to apply for and obtain a License, Notification, or Certification from the FDA prior to importation depending on classification.
Class I “Licensed” medical devices – 1 year processing time
Gloves, surgical and exam
HIV test kits
Contact lens (correctcive and cosmetic)
Class II “Notified” medical devices – 6-8 months processing time
Physical therapy equipment
HIV test kits, research
Class III “general” medical device” – 2 to 6 days processing time (typical)
All other medical devices
Including stents and PTCA catheters
Proof of regulatory approval in the country of origin is a firm requirement for medical device registration in Thailand. Certain documents such as the Free Sale Certificate and ISO certificate must be authenticated by the territorial Thai Consulate. Obtaining authentication can take 2 to 4 weeks.
Standard application processing for general medical device registration in Thailand takes 2 weeks. This can extend out to 4 months if multiple FDA inquiries. Official processing fees are approximately US$100 per application. Import Licenses are valid through the validity period of the Certificate of Free Sales, up to a maximum of 5 years.
Thailand medical device registration for Notifice and Registered devices requires full technical documentation in support of the application. Processing time run 6 to 12 months.
The Thai FDA has announced plans to implement ASEAN MDD medical device classification guidelines to take effect in the near future. At that time, Class D, C and B devices will require Asian CSDT files in support of their product registration applications impacting registration fees and timelines.
Further, the Thai FDA is preparing to charge a fee for the Expert Review procedure of the Import License application process. Currently there is no additional fee for the Expert Review that is applied to the registration process for high and medium risk devices and certain low risk devices.
The application of the new fee is to correspond with adoption of a new device classification system based on ASEAN Medical Devices Directive guidelines. Then the Expert Review fees would vary by device classification, as below:
Class 1 – THB 0 or THB 25,000 (US$740)
Class 2 – THB 38,000 (US$1,120)
Class 3 – THB 63,000 (US$1,850)
Class 4 – THB 88,000 (US$2,590)
Contact Asia Actual for assistance with Medical Deivce Regulations in Thailand.