Class I “Licensed” IVD devices – 1 year processing time
HIV test kits
Class II “Notified” IVD devices – 6-8 months processing time
HIV test kits, research
Class III “general” medical device” – 2 to 6 days processing time (typical)
All other IVD devices and test kits
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 weeks. 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 IVD devices. Asia Actual has experienced, top level consultants in Thailand to manage the application process.