| Regulatory Authority | Thai Food and Drug Administration (TFDA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, II, III, IV |
| Medical Device Regulations | Laws and Regulations | Click Here |
| IVD Classification | Type 1, Type 2, Type 3, Type 4 |
| Registration Process | Permission on Medical Devices | Click Here |
| Registration Timeline | 6 to 10 months depends on classification |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Thai Language |
| Additional Information | There are 3 pathways for medical device registration in Thailand: Full evaluation Concise pathway Reliance program |