Medical device registration by risk class
Medical devices follow one of three routes depending on the risk class: notification for class 1, a detailed listing with a CSDT technical file for class 2 and 3, and a licence for class 4. Getting the class right first saves months.
How the work runs
The five stages, end to end
- 1
Risk classification
Handled by: Us · Time: 5 days
We classify the device and tell you which of the three routes applies.
- 2
Establishment registration
Handled by: Us · Time: 30 days
Registration of the importing company, with a qualified supervisor where required.
- 3
Technical file
Handled by: Manufacturer and us · Time: 21–60 days
ISO 13485, test reports, risk management and clinical evidence, depending on the class.
- 4
Submission and review
Handled by: Thai FDA · Time: 15–180 days
Class 1 is the fastest; class 4 takes the longest and may involve expert review.
- 5
Labelling and annual report
Handled by: Us · Time: 10 days
Thai label and instructions, plus the annual import and sales report between 1 January and 31 March.
Costs
| Item | Amount | Source |
|---|---|---|
| Government fees | Set by risk class 1 to 4 | |
| Standard testing, class 2 and above | Quoted per model | |
| Our service fee | Quoted per case |