IVD device registration in the Thailand 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 2016 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 required, but reference country approval (from the US, EU, Canada, Japan or Australia) may be used instead.
Certain documents such as the Free Sale Certificate, ISO certificate and Foreign Agency Agreement must be authenticated by the territorial Thai Consulate. Obtaining authentication can take 2 to 3 months.
The application processing takes 2 to 4 weeeks. FDA processing fees total US$100 per application. Import Licenses are valid for 5 years for Class III medical devices.
Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual has experienced, top level consultants in Thailand to manage the application process.