| 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 |
| Device Classification Guidelines | This classification aligns with ASEAN Medical Device Directive (AMDD) to ensure safety and performance, and to protect consumers and patients. | Click Here |
| Registration Process | Permission on Medical Devices | Click Here |
| Registration Timeline | 6 to 10 months depends on classification |
| Conformity Assessment Route |
Process Flow for Medical Device Manufacturer / Importer | Click Here |
| Technical Documentation Format |
Submission Dossier for Class 1-4 Medical Devices | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Thai Language |
| Clinical Trials Information |
Medical device clinical research investigational device exemption (IDE) | Click Here |
| Declaration of Conformity |
Template | Click Here |
| Adverse Event Reporting Timelines | In the case of an incident occurring in the country
|
| Field Safety Corrective Action |
Rules, Procedures and Conditions for Preparation of Reports on Medical Device Malfunctions or Adverse Events Occurring to Consumers and Reports on Field Safety Corrective Actions | Click Here |
| Advertising and Promotions |
There are two types of advertising permission requests: 1. Advertising to the public |
| Additional Information | There are 3 pathways for medical device registration in Thailand: Full evaluation Concise pathway Reliance program |
| Contact Phone | (66) 2590 7000 |
| Contact Email | saraban@fda.moph.go.th |
| Contact Address | Food and Drug Administration 88/24 Tiwanon Road, Talat Khwan, Mueang Nonthaburi, Nonthaburi, Thailand 11000 |